ADHDPhase 4NCT04284059

Adjuvant Effects of Vitamin A and Vitamin D Supplementation on Treatment of Children With ADHD

A Phase 4 study testing vitamin AD and vitamin D in people with ADHD, run by Chen Li at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 6 to 12 years
Conditions the study is for: ADHD
What is being tested?: vitamin AD and vitamin D
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 504 participants
Where: 3 sitesChina
Study dates: 25 Feb 2021to 30 Aug 2022
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Diagnose of ADHD according to DSM-5
Aged 6-12 years
Intelligence quotient (IQ) ≥70
Receiving methylphenidate (trade name Concerta) 18-54 mg/day once a day (began with 18 mg/day for a week and titrated gradually to the optimum dose not more than 54 mg/day).

Who cannot join

Inconsistent or changing dose of methylphenidate during the participation period
Use of anticonvulsant drugs or hydrocortisone
Suffering from other neurological disorders and mental diseases now or in the past, such as convulsions, anxiety and depression
Suffer from metabolic disorders such as cholestasis, liver dysfunction, pancreatic insufficiency, measles, diarrhea, respiratory illness, severe inflammation or malnutrition, etc.
Use of vitamins and vitamin-containing products
IQ≤70
The serum concentration of vitamin A >1.05 umol/L and/ or vitamin D >50 nmol/L

Trial locations and contacts

3 sites in 1 country.

Li Chen, doctor contact

136 7762 0103 ext. +86

chenli2012@126.com

China3 sites, 3 recruiting

the First Hospital of Jilin University
Changchun, Jilin, 130012
yong F Jia, doctor, 13943003914 ext. +86, erkekangfujia@163.com
Not yet recruiting
Growth, Development and Mental health of Children and Adolescence Center
Chongqing, Chongqing Municipality, 400014
Li Chen, MD, (+86)136 7762 0103 ext. +86, chenli2012@126.com
Recruiting
Qilu Hospital of Shandong University
Jinan, Shandonng, 250012
hua Ai Cao, Doctor, 18560086317 ext. +86, xinercah@163.com
Not yet recruiting

Other trials in China

About this study

Official title: Adjuvant Effects of Vitamin A and Vitamin D Supplementation on Treatment of Children With ADHD:A Randomized, Double Blind, Placebo-controlled, Multicentric Trial.

Around 7.2% of children around the world are suffering from ADHD. On account of current medical treatment, a high remission rate can be reached for ADHD. Nevertheless, patients have to face a number of side effects associated with the treatment. It was informed that patients of ADHD have a tendency to vitamin A and vitamin D deficiency. The aim of the study is to determine the effect of vitamin A and vitamin D supplementation as adjunctive therapy to methylphenidate on symptoms of ADHD. 504 subjects aged 6-12 years with a diagnosis of ADHD based on DSM-5 criteria are randomly assigned into three groups to receive vitamin A 6000 IU/day and vitamin D 2100 IU/day, or vitamin D 2100 IU/day or placebo adding to methylphenidate for 8 weeks. Symptoms severity is assessed by Vanderbilt Assessment Scales and Questionnaire - Children with Difficulties at weeks 0, 4, and 8. Serum levels of retinol and 25(OH)D are measured at baseline and after 8 weeks. All the other sociodemographic data are assessed. The study can give more references on the application of vitamin A and vitamin D in addition to methylphenidate to ADHD. Future research is needed to clarify mechanism of vitamin A and vitamin D on ADHD.

Read the detailed description

Procedures The patients showed deficiency or insufficiency in vitamin A (≤1.05 umol/ L) and vitamin D (≤50 nmol/L) are stratified by gender and randomly assigned in double-blind fashion in a 1:1:1 ratio to the vitamin AD supplementation group, vitamin D supplementation group or the placebo group. The participants will be given the related interventions. Placebo constituents by oily liquids without vitamin A and vitamin D. Placebo, vitamin AD and vitamin D are identical in the appearance to guarantee blind. These patients will be followed up at weeks 4 and 8 to evaluate the changes of ADHD symptoms after adding the adjunctive therapy to methylphenidate. And serum concentration of retinol and 25(OH)D are measured at weeks 8. Accordingly, the placebo group and vitamin D group will be prescribed with vitamin A and vitamin D supplementation on the grounds of retinol and 25 (OH)D concentration after the study.
Demographic questionnaire and clinical data The demographic questionnaire is completed by the child's primary caregiver, detailing child's name, gender, date of birth, height, weight, blood pressure, heart rate ; supplementation of vitamin A/D products or vitamin A/D-containing products. Clinical data will be ascertained from the medical records, including information about DSM-5 diagnosis, disease classification, current treatment, and comorbid conditions.
Sample size This study is a randomized double-blind controlled trial. Intervention groups are vitamin AD group and vitamin D group, control group is placebo group. The primary outcome index is changes in ADHD symptoms evaluated by Vanderbilt Assessment Scales and Questionnaire - Children with Difficulties (QCD) in the last 4 weeks or 8 weeks. The second outcome is the serum concentration of vitamin A and vitamin D. Conner's Parent Rating Scale (CPRS) was considered as the main outcome in the previous literature, the mean ± SD of ADHD index was 55.84 ± 10.2, 56.79 ± 9.6 for vitamin D + methylphenidate(n = 25), placebo + methylphenidate (n = 29) respectively. The investigators cautiously presume that the mean ± SD for vitamin AD + methylphenidate is 54 ± 9.88. Considering 0.05 of the alpha and 0.80 of power, a sample of 453 subjects divided among 3 groups are calculated by PASS 2020. And 504 subjects are enrolled in the study based on the dropout rate of 10%.
Statistical analysis All the data are analyzed using SPSS 19.0. The normality of variables are assessed by Kolmogorov Smirnov test. Comparison of parametric and nonparametric variables between groups are examined by F test and Kruskal-Wallis test, respectively. Paired t-test and Wilcoxon signed-rank test are used to investigate within-group differences. Confounding factors are adjusted by the analysis of covariance.
Bias control the investigators will describe both responders and non-responders on demographic questionnaire and clinical data in detail to assess the selection bias. And in order to decrease the dropout rate, the investigators will contact with the patient's parents about compliance to therapy by Wechat, E-mail, sometimes telephone contact is necessary.
Ethical matters and data protection The patients participated in the study will sign the informed consent (obtained from the guardian). And this study was approved by the local ethics committee . Patient's name will be abbreviated and the research data will be assigned a code then to provide to the researcher. The authorization from parents on the patient's health information remains valid until the study is completed. After that, researchers will delete private information from the study record.

Conditions: ADHD
Being tested: Placebos, vitamin AD, vitamin D
Keywords: Vitamin A, Vitamin D, Methylphenidate, ADHD
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlacebosDrug
Placebo, vitamin AD and vitamin D are identical in the appearance to guarantee blind. The patients need to administrate 3 capsules once a day for 8 weeks.
vitamin ADDietary supplement
A vitamin AD capsule contains vitamin A 2000 IU and vitamin D 700 IU. The patients need to administrate 3 capsules once a day for 8 weeks.
vitamin DDietary supplement
A vitamin D capsule contains vitamin D 400 IU. The patients need to asministrate 6 capsules/time, once a day for 2 weeks, then change to 5 capsules/time, once a day for 6 weeks.

Study groups in NCT04284059
Study group	Role	What they receive
vitamin AD group	Active comparator	The patients aged 6-12 with a diagnose of ADHD of this group is deficient or insufficient in vitamin A and vitamin D. They will receive vitamin A 6000 IU/day and vitamin D 2100 IU/day supplementation in addition to methylphenidate for 8 weeks. Receives: Dietary Supplement: vitamin AD
vitamin D group	Experimental	The patients aged 6-12 with a diagnose of ADHD of this group is deficient or insufficient in vitamin A and vitamin D. They will receive vitamin D 2100 IU/day supplementation in addition to methylphenidate for 8 weeks. After the study, vitamin D group will be administrated with vitamin A on the basis of serum retinol concentration after the study. Receives: Dietary Supplement: vitamin D
placebo group	Placebo comparator	The patients aged 6-12 with a diagnose of ADHD of this group is deficient or insufficient in vitamin A and vitamin D. They will receive placebo once a day in addition to methylphenidate for 8 weeks. After the study, the placebo group will be prescribed with vitamin A and vitamin D supplementation on the grounds of retinol and 25 (OH)D concentration. Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt parent assessment scale
The Vanderbilt parent assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 49-56 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic.
The scoring standard for Predominantly Inattentive subtype: Must score a 2 or 3 on 6 out of 9 items on questions 1-9 AND Score a 4 or 5 on any of the Performance questions 49-56. The higher scores mean a worse outcome.
Measured: at baseline
The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt teacher assessment scale
The Vanderbilt teacher assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 36-43 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic.
The scoring standard for Predominantly Inattentive subtype: Must score a 2 or 3 on 6 out of 9 items on questions 1-9 AND Score a 4 or 5 on any of the Performance questions 36-43. The higher scores mean a worse outcome.
Measured: at baseline
The changes in ADHD clinical symptoms-Predominantly Hyperactive/Impulsive subtype estimated by Chinese version of Vanderbilt parent assessment scale
The Vanderbilt parent assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 49-56 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic.
The scoring standard for Predominantly Hyperactive/Impulsive subtype: Must score a 2 or 3 on 6 out of 9 items on questions 10-18 AND Score a 4 or 5 on any of the Performance questions 49-56. The higher scores mean a worse outcome.
Measured: at baseline
The changes in ADHD clinical symptoms-Predominantly Hyperactive/Impulsive subtype estimated by Chinese version of Vanderbilt teacher assessment scale
The Vanderbilt teacher assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 36-43 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic.
The scoring standard for Predominantly Hyperactive/Impulsive subtype: Must score a 2 or 3 on 6 out of 9 items on questions 10-18 AND Score a 4 or 5 on any of the Performance questions 36-43. The higher scores mean a worse outcome.
Measured: at baseline
The changes in ADHD clinical symptoms-ADHD Combined Inattention/Hyperactivity estimated by Chinese version of Vanderbilt parent assessment scale
The Vanderbilt parent assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 49-56 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic.
The scoring standard for ADHD Combined Inattention/Hyperactivity: Must score a 2 or 3 on 6 out of 9 items not only on questions 1-9 but also on questions 10-18. AND Score a 4 or 5 on any of the Performance questions 49-56. The higher scores mean a worse outcome.
Measured: at baseline
The changes in ADHD clinical symptoms-ADHD Combined Inattention/Hyperactivity estimated by Chinese version of Vanderbilt teacher assessment scale
The Vanderbilt teacher assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 36-43 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic.
The scoring standard for ADHD Combined Inattention/Hyperactivity: Must score a 2 or 3 on 6 out of 9 items not only on questions 1-9 but also on questions 10-18. AND Score a 4 or 5 on any of the Performance questions 36-43. The higher scores mean a worse outcome.
Measured: at baseline
The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt parent follow-up assessment
The Vanderbilt parent follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic).
The scoring standard for Predominantly Inattentive subtype: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.
Measured: at weeks 4 and 8
The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt teacher follow-up assessment
The Vanderbilt teacher follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic).
The scoring standard for Predominantly Inattentive subtype: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.
Measured: at weeks 4 and 8
The changes in ADHD clinical symptoms-Predominantly Hyperactive/Impulsive subtype estimated by Chinese version of Vanderbilt parent follow-up assessment
The Vanderbilt parent follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic).
The scoring standard for Predominantly Hyperactive/Impulsive subtype: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.
Measured: at weeks 4 and 8
The changes in ADHD clinical symptoms-Predominantly Hyperactive/Impulsive subtype estimated by Chinese version of Vanderbilt teacher follow-up assessment
The Vanderbilt teacher follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic).
The scoring standard for Predominantly Hyperactive/Impulsive subtype: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.
Measured: at weeks 4 and 8
The changes in ADHD clinical symptoms-ADHD Combined Inattention/Hyperactivity estimated by Chinese version of Vanderbilt parent follow-up assessment
The Vanderbilt parent follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic).
The scoring standard for ADHD Combined Inattention/Hyperactivity: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.
Measured: at weeks 4 and 8
The changes in ADHD clinical symptoms-ADHD Combined Inattention/Hyperactivity estimated by Chinese version of Vanderbilt teacher follow-up assessment
The Vanderbilt teacher follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic).
The scoring standard for ADHD Combined Inattention/Hyperactivity: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.
Measured: at weeks 4 and 8
The changes in ADHD clinical symptoms
The Questionnaire - Children with Difficulties (QCD) measures the daily-life problems in children aged 6-18 years during the special time of the day, including in the morning, during school, after school, in the evening, and overall difficulties over the entire day and night. It has been proved the Chinese version of QCD has good validity and reliability. Filled in by the parents, the scale consists of 20 questions with regard to ADHD-related difficulties. Each question is scored on a four-point scale: 0 = completely disagree, 1 = somewhat (partially) agree, 2 = mostly agree, and 3 = completely agree. Score of 30 - 35 is considered as cut-off value for functional impairment and score of less than 30 is considered as functional impairment (Full marks: 57). The lower scores indicate lower life functioning and more difficulty in children's daily activities.
Measured: at baseline, weeks 4 and 8

Secondary outcomes (2)

Serum concentration of vitamin A.
Vitamin A state is measured by the serum concentration of retinol through high performance liquid chromatography (HPLC) from 2 milliliter of venous blood. The vitamin A status is categorized based on serum retinol: <0.35 µmol/L is considered very deficient, 0.35-0.7 µmol/L deficient, 0.7-1.05 µmol/L marginal, 1.05-2.56 µmol/L adequate, and >2.56 µmol/L toxic. Too low or too high concentrations are harmful
Measured: at baseline and weeks 8
Serum concentration of vitamin D.
Vitamin D state is measured by the serum concentration of 25OHD through high performance liquid chromatography (HPLC) from 2 milliliter of venous blood. The values of serum vitamin D level are classified into 4 categories: <30 nmol/L is regarded as deficiency, 30-50 nmol/L insufficiency, 50-250 nmol/L normal, and >250 nmol/L toxic . Too low or too high concentrations are harmful。
Measured: at baseline and weeks 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Feb 202130 Aug 2022

First posted25 Feb 2020
Study start25 Feb 2021
Primary completion30 May 2022 (estimated)
Study completion30 Aug 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for ADHDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The patients showed deficiency or insufficiency in vitamin A (≤1.05 umol/ L) and vitamin D (≤50 nmol/L) are randomly assigned in double-blind fashion in a 1:1:1 ratio to the vitamin AD supplementation group, vitamin D supplementation group or the placebo group. Vitamin AD supplementation group will be administrated vitamin AD capsules (3 capsules/time, once a day for 8 weeks), which contain vitamin A (2000 IU/capsule) and vitamin D (700 IU/capsule). Vitamin D supplementation group will be administrated vitamin D capsules (400 IU/capsule, 6 capsules/time, once a day for 2 weeks, then change to 5 capsules/time, once a day for 6 weeks). The placebo capsules given to the placebo group (3 capsules/time, once a day for 8 weeks), consists of oily liquids which do not contain vitamin A and vitamin D, and were produced in strict accordance with China's drug management and packaging requirements for placebo by Shandong DYNE Marine Biopharmaceutical Co., Ltd in China.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 504 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04284059
Sponsor's protocol ID: CHENLI
Status last verified: Apr 2021
First submitted: 20 Feb 2020
Last updated: 6 Apr 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Data is confidential during the study.

Publications

Dehbokri N, Noorazar G, Ghaffari A, Mehdizadeh G, Sarbakhsh P, Ghaffary S. Effect of vitamin D treatment in children with attention-deficit hyperactivity disorder. World J Pediatr. 2019 Feb;15(1):78-84. doi: 10.1007/s12519-018-0209-8. Epub 2018 Nov 19.
PubMed 30456564
Elshorbagy HH, Barseem NF, Abdelghani WE, Suliman HAI, Al-Shokary AH, Abdulsamea SE, Elsadek AE, Abdel Maksoud YH, Nour El Din DMAE. Impact of Vitamin D Supplementation on Attention-Deficit Hyperactivity Disorder in Children. Ann Pharmacother. 2018 Jul;52(7):623-631. doi: 10.1177/1060028018759471. Epub 2018 Feb 18.
PubMed 29457493
Evans E, Piccio L, Cross AH. Use of Vitamins and Dietary Supplements by Patients With Multiple Sclerosis: A Review. JAMA Neurol. 2018 Aug 1;75(8):1013-1021. doi: 10.1001/jamaneurol.2018.0611.
PubMed 29710293
Faraone SV. The pharmacology of amphetamine and methylphenidate: Relevance to the neurobiology of attention-deficit/hyperactivity disorder and other psychiatric comorbidities. Neurosci Biobehav Rev. 2018 Apr;87:255-270. doi: 10.1016/j.neubiorev.2018.02.001. Epub 2018 Feb 8.
PubMed 29428394
Fasihpour B, Moayeri H, Shariat M, Keihanidoust Z, Effatpanah M, Khedmat L. Vitamin D deficiency in school-age Iranian children with attention-deficit/hyperactivity disorder (ADHD) symptoms: A critical comparison with healthy controls. Child Neuropsychol. 2020 May;26(4):460-474. doi: 10.1080/09297049.2019.1665638. Epub 2019 Sep 13.
PubMed 31514566
Fragoso YD, Stoney PN, McCaffery PJ. The evidence for a beneficial role of vitamin A in multiple sclerosis. CNS Drugs. 2014 Apr;28(4):291-9. doi: 10.1007/s40263-014-0148-4.
PubMed 24557746
Gallo EF, Posner J. Moving towards causality in attention-deficit hyperactivity disorder: overview of neural and genetic mechanisms. Lancet Psychiatry. 2016 Jun;3(6):555-67. doi: 10.1016/S2215-0366(16)00096-1. Epub 2016 May 13.
PubMed 27183902
Hinshaw SP. Attention Deficit Hyperactivity Disorder (ADHD): Controversy, Developmental Mechanisms, and Multiple Levels of Analysis. Annu Rev Clin Psychol. 2018 May 7;14:291-316. doi: 10.1146/annurev-clinpsy-050817-084917. Epub 2017 Dec 8.
PubMed 29220204
Lopes FM, da Motta LL, De Bastiani MA, Pfaffenseller B, Aguiar BW, de Souza LF, Zanatta G, Vargas DM, Schonhofen P, Londero GF, de Medeiros LM, Freire VN, Dafre AL, Castro MA, Parsons RB, Klamt F. RA Differentiation Enhances Dopaminergic Features, Changes Redox Parameters, and Increases Dopamine Transporter Dependency in 6-Hydroxydopamine-Induced Neurotoxicity in SH-SY5Y Cells. Neurotox Res. 2017 May;31(4):545-559. doi: 10.1007/s12640-016-9699-0. Epub 2017 Feb 2.
PubMed 28155214
McCaffery P, Drager UC. High levels of a retinoic acid-generating dehydrogenase in the meso-telencephalic dopamine system. Proc Natl Acad Sci U S A. 1994 Aug 2;91(16):7772-6. doi: 10.1073/pnas.91.16.7772.
PubMed 8052659
Mohammadpour N, Jazayeri S, Tehrani-Doost M, Djalali M, Hosseini M, Effatpanah M, Davari-Ashtiani R, Karami E. Effect of vitamin D supplementation as adjunctive therapy to methylphenidate on ADHD symptoms: A randomized, double blind, placebo-controlled trial. Nutr Neurosci. 2018 Apr;21(3):202-209. doi: 10.1080/1028415X.2016.1262097. Epub 2016 Dec 7.
PubMed 27924679
Moretti R, Morelli ME, Caruso P. Vitamin D in Neurological Diseases: A Rationale for a Pathogenic Impact. Int J Mol Sci. 2018 Jul 31;19(8):2245. doi: 10.3390/ijms19082245.
PubMed 30065237
Ono K, Yamada M. Vitamin A and Alzheimer's disease. Geriatr Gerontol Int. 2012 Apr;12(2):180-8. doi: 10.1111/j.1447-0594.2011.00786.x. Epub 2011 Dec 23.
PubMed 22221326
Palacios C, Gonzalez L. Is vitamin D deficiency a major global public health problem? J Steroid Biochem Mol Biol. 2014 Oct;144 Pt A:138-45. doi: 10.1016/j.jsbmb.2013.11.003. Epub 2013 Nov 12.
PubMed 24239505
Pertile RA, Cui X, Eyles DW. Vitamin D signaling and the differentiation of developing dopamine systems. Neuroscience. 2016 Oct 1;333:193-203. doi: 10.1016/j.neuroscience.2016.07.020. Epub 2016 Jul 20.
PubMed 27450565

Want to know more?

Li Chen, doctor

136 7762 0103 ext. +86

chenli2012@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adjuvant Effects of Vitamin A and Vitamin D Supplementation on Treatment of Children With ADHD:A Randomized, Double Blind, Placebo-controlled, Multicentric Trial.
ClinicalTrials.gov ID: NCT04284059
Acronym / sponsor ID: CHENLI
Conditions: ADHD
Keywords: Vitamin A, Vitamin D, Methylphenidate, ADHD
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 504 participants (estimated)
Lead sponsor: Chen LiUniversity, hospital or other
Study start: 25 Feb 2021 (actual)
Primary completion: 30 May 2022 (estimated)
Study completion: 30 Aug 2022 (estimated)
First posted: 25 Feb 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Procedures The patients showed deficiency or insufficiency in vitamin A (≤1.05 umol/ L) and vitamin D (≤50 nmol/L) are stratified by gender and randomly assigned in double-blind fashion in a 1:1:1 ratio to the vitamin AD supplementation group, vitamin D supplementation group or the placebo group. The participants will be given the related interventions. Placebo constituents by oily liquids without vitamin A and vitamin D. Placebo, vitamin AD and vitamin D are identical in the appearance to guarantee blind. These patients will be followed up at weeks 4 and 8 to evaluate the changes of ADHD symptoms after adding the adjunctive therapy to methylphenidate. And serum concentration of retinol and 25(OH)D are measured at weeks 8. Accordingly, the placebo group and vitamin D group will be prescribed with vitamin A and vitamin D supplementation on the grounds of retinol and 25 (OH)D concentration after the study.
Demographic questionnaire and clinical data The demographic questionnaire is completed by the child's primary caregiver, detailing child's name, gender, date of birth, height, weight, blood pressure, heart rate ; supplementation of vitamin A/D products or vitamin A/D-containing products. Clinical data will be ascertained from the medical records, including information about DSM-5 diagnosis, disease classification, current treatment, and comorbid conditions.
Sample size This study is a randomized double-blind controlled trial. Intervention groups are vitamin AD group and vitamin D group, control group is placebo group. The primary outcome index is changes in ADHD symptoms evaluated by Vanderbilt Assessment Scales and Questionnaire - Children with Difficulties (QCD) in the last 4 weeks or 8 weeks. The second outcome is the serum concentration of vitamin A and vitamin D. Conner's Parent Rating Scale (CPRS) was considered as the main outcome in the previous literature, the mean ± SD of ADHD index was 55.84 ± 10.2, 56.79 ± 9.6 for vitamin D + methylphenidate(n = 25), placebo + methylphenidate (n = 29) respectively. The investigators cautiously presume that the mean ± SD for vitamin AD + methylphenidate is 54 ± 9.88. Considering 0.05 of the alpha and 0.80 of power, a sample of 453 subjects divided among 3 groups are calculated by PASS 2020. And 504 subjects are enrolled in the study based on the dropout rate of 10%.
Statistical analysis All the data are analyzed using SPSS 19.0. The normality of variables are assessed by Kolmogorov Smirnov test. Comparison of parametric and nonparametric variables between groups are examined by F test and Kruskal-Wallis test, respectively. Paired t-test and Wilcoxon signed-rank test are used to investigate within-group differences. Confounding factors are adjusted by the analysis of covariance.
Bias control the investigators will describe both responders and non-responders on demographic questionnaire and clinical data in detail to assess the selection bias. And in order to decrease the dropout rate, the investigators will contact with the patient's parents about compliance to therapy by Wechat, E-mail, sometimes telephone contact is necessary.
Ethical matters and data protection The patients participated in the study will sign the informed consent (obtained from the guardian). And this study was approved by the local ethics committee . Patient's name will be abbreviated and the research data will be assigned a code then to provide to the researcher. The authorization from parents on the patient's health information remains valid until the study is completed. After that, researchers will delete private information from the study record.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3
Model description: The patients showed deficiency or insufficiency in vitamin A (≤1.05 umol/ L) and vitamin D (≤50 nmol/L) are randomly assigned in double-blind fashion in a 1:1:1 ratio to the vitamin AD supplementation group, vitamin D supplementation group or the placebo group. Vitamin AD supplementation group will be administrated vitamin AD capsules (3 capsules/time, once a day for 8 weeks), which contain vitamin A (2000 IU/capsule) and vitamin D (700 IU/capsule). Vitamin D supplementation group will be administrated vitamin D capsules (400 IU/capsule, 6 capsules/time, once a day for 2 weeks, then change to 5 capsules/time, once a day for 6 weeks). The placebo capsules given to the placebo group (3 capsules/time, once a day for 8 weeks), consists of oily liquids which do not contain vitamin A and vitamin D, and were produced in strict accordance with China's drug management and packaging requirements for placebo by Shandong DYNE Marine Biopharmaceutical Co., Ltd in China.

Arm	Type	Receives
vitamin AD group	Active comparator	Dietary Supplement: vitamin ADThe patients aged 6-12 with a diagnose of ADHD of this group is deficient or insufficient in vitamin A and vitamin D. They will receive vitamin A 6000 IU/day and vitamin D 2100 IU/day supplementation in addition to methylphenidate for 8 weeks.
vitamin D group	Experimental	Dietary Supplement: vitamin DThe patients aged 6-12 with a diagnose of ADHD of this group is deficient or insufficient in vitamin A and vitamin D. They will receive vitamin D 2100 IU/day supplementation in addition to methylphenidate for 8 weeks. After the study, vitamin D group will be administrated with vitamin A on the basis of serum retinol concentration after the study.
placebo group	Placebo comparator	Drug: PlacebosThe patients aged 6-12 with a diagnose of ADHD of this group is deficient or insufficient in vitamin A and vitamin D. They will receive placebo once a day in addition to methylphenidate for 8 weeks. After the study, the placebo group will be prescribed with vitamin A and vitamin D supplementation on the grounds of retinol and 25 (OH)D concentration.

Who may qualify

Ages: 6 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Diagnose of ADHD according to DSM-5
Aged 6-12 years
Intelligence quotient (IQ) ≥70
Receiving methylphenidate (trade name Concerta) 18-54 mg/day once a day (began with 18 mg/day for a week and titrated gradually to the optimum dose not more than 54 mg/day).

Key exclusion criteria (7 listed)

Inconsistent or changing dose of methylphenidate during the participation period
Use of anticonvulsant drugs or hydrocortisone
Suffering from other neurological disorders and mental diseases now or in the past, such as convulsions, anxiety and depression
Suffer from metabolic disorders such as cholestasis, liver dysfunction, pancreatic insufficiency, measles, diarrhea, respiratory illness, severe inflammation or malnutrition, etc.
Use of vitamins and vitamin-containing products

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlacebosPlacebo, vitamin AD and vitamin D are identical in the appearance to guarantee blind. The patients need to administrate 3 capsules once a day for 8 weeks.	Drug	placebo group
vitamin ADA vitamin AD capsule contains vitamin A 2000 IU and vitamin D 700 IU. The patients need to administrate 3 capsules once a day for 8 weeks.	Dietary supplement	vitamin AD group
vitamin DA vitamin D capsule contains vitamin D 400 IU. The patients need to asministrate 6 capsules/time, once a day for 2 weeks, then change to 5 capsules/time, once a day for 6 weeks.	Dietary supplement	vitamin D group

Primary outcome

The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt parent assessment scale
Time frame: at baseline
The Vanderbilt parent assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 49-56 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic. The scoring standard for Predominantly Inattentive subtype: Must score a 2 or 3 on 6 out of 9 items on questions 1-9 AND Score a 4 or 5 on any of the Performance questions 49-56. The higher scores mean a worse outcome.
The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt teacher assessment scale
Time frame: at baseline
The Vanderbilt teacher assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 36-43 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic. The scoring standard for Predominantly Inattentive subtype: Must score a 2 or 3 on 6 out of 9 items on questions 1-9 AND Score a 4 or 5 on any of the Performance questions 36-43. The higher scores mean a worse outcome.
The changes in ADHD clinical symptoms-Predominantly Hyperactive/Impulsive subtype estimated by Chinese version of Vanderbilt parent assessment scale
Time frame: at baseline
The Vanderbilt parent assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 49-56 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic. The scoring standard for Predominantly Hyperactive/Impulsive subtype: Must score a 2 or 3 on 6 out of 9 items on questions 10-18 AND Score a 4 or 5 on any of the Performance questions 49-56. The higher scores mean a worse outcome.
The changes in ADHD clinical symptoms-Predominantly Hyperactive/Impulsive subtype estimated by Chinese version of Vanderbilt teacher assessment scale
Time frame: at baseline
The Vanderbilt teacher assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 36-43 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic. The scoring standard for Predominantly Hyperactive/Impulsive subtype: Must score a 2 or 3 on 6 out of 9 items on questions 10-18 AND Score a 4 or 5 on any of the Performance questions 36-43. The higher scores mean a worse outcome.
The changes in ADHD clinical symptoms-ADHD Combined Inattention/Hyperactivity estimated by Chinese version of Vanderbilt parent assessment scale
Time frame: at baseline
The Vanderbilt parent assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 49-56 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic. The scoring standard for ADHD Combined Inattention/Hyperactivity: Must score a 2 or 3 on 6 out of 9 items not only on questions 1-9 but also on questions 10-18. AND Score a 4 or 5 on any of the Performance questions 49-56. The higher scores mean a worse outcome.
The changes in ADHD clinical symptoms-ADHD Combined Inattention/Hyperactivity estimated by Chinese version of Vanderbilt teacher assessment scale
Time frame: at baseline
The Vanderbilt teacher assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 36-43 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic. The scoring standard for ADHD Combined Inattention/Hyperactivity: Must score a 2 or 3 on 6 out of 9 items not only on questions 1-9 but also on questions 10-18. AND Score a 4 or 5 on any of the Performance questions 36-43. The higher scores mean a worse outcome.
The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt parent follow-up assessment
Time frame: at weeks 4 and 8
The Vanderbilt parent follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic). The scoring standard for Predominantly Inattentive subtype: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.
The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt teacher follow-up assessment
Time frame: at weeks 4 and 8
The Vanderbilt teacher follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic). The scoring standard for Predominantly Inattentive subtype: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.
The changes in ADHD clinical symptoms-Predominantly Hyperactive/Impulsive subtype estimated by Chinese version of Vanderbilt parent follow-up assessment
Time frame: at weeks 4 and 8
The Vanderbilt parent follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic). The scoring standard for Predominantly Hyperactive/Impulsive subtype: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.
The changes in ADHD clinical symptoms-Predominantly Hyperactive/Impulsive subtype estimated by Chinese version of Vanderbilt teacher follow-up assessment
Time frame: at weeks 4 and 8
The Vanderbilt teacher follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic). The scoring standard for Predominantly Hyperactive/Impulsive subtype: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.
The changes in ADHD clinical symptoms-ADHD Combined Inattention/Hyperactivity estimated by Chinese version of Vanderbilt parent follow-up assessment
Time frame: at weeks 4 and 8
The Vanderbilt parent follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic). The scoring standard for ADHD Combined Inattention/Hyperactivity: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.
The changes in ADHD clinical symptoms-ADHD Combined Inattention/Hyperactivity estimated by Chinese version of Vanderbilt teacher follow-up assessment
Time frame: at weeks 4 and 8
The Vanderbilt teacher follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic). The scoring standard for ADHD Combined Inattention/Hyperactivity: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.
The changes in ADHD clinical symptoms
Time frame: at baseline, weeks 4 and 8
The Questionnaire - Children with Difficulties (QCD) measures the daily-life problems in children aged 6-18 years during the special time of the day, including in the morning, during school, after school, in the evening, and overall difficulties over the entire day and night. It has been proved the Chinese version of QCD has good validity and reliability. Filled in by the parents, the scale consists of 20 questions with regard to ADHD-related difficulties. Each question is scored on a four-point scale: 0 = completely disagree, 1 = somewhat (partially) agree, 2 = mostly agree, and 3 = completely agree. Score of 30 - 35 is considered as cut-off value for functional impairment and score of less than 30 is considered as functional impairment (Full marks: 57). The lower scores indicate lower life functioning and more difficulty in children's daily activities.

2 secondary outcomes

Serum concentration of vitamin A.
Time frame: at baseline and weeks 8
Serum concentration of vitamin D.
Time frame: at baseline and weeks 8

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
Background: PubMed 30456564Dehbokri N, Noorazar G, Ghaffari A, Mehdizadeh G, Sarbakhsh P, Ghaffary S. Effect of vitamin D treatment in children with attention-deficit hyperactivity disorder. World J Pediatr. 2019 Feb;15(1):78-84. doi: 10.1007/s12519-018-0209-8. Epub 2018 Nov 19.
Background: PubMed 29457493Elshorbagy HH, Barseem NF, Abdelghani WE, Suliman HAI, Al-Shokary AH, Abdulsamea SE, Elsadek AE, Abdel Maksoud YH, Nour El Din DMAE. Impact of Vitamin D Supplementation on Attention-Deficit Hyperactivity Disorder in Children. Ann Pharmacother. 2018 Jul;52(7):623-631. doi: 10.1177/1060028018759471. Epub 2018 Feb 18.
Background: PubMed 29710293Evans E, Piccio L, Cross AH. Use of Vitamins and Dietary Supplements by Patients With Multiple Sclerosis: A Review. JAMA Neurol. 2018 Aug 1;75(8):1013-1021. doi: 10.1001/jamaneurol.2018.0611.
Background: PubMed 29428394Faraone SV. The pharmacology of amphetamine and methylphenidate: Relevance to the neurobiology of attention-deficit/hyperactivity disorder and other psychiatric comorbidities. Neurosci Biobehav Rev. 2018 Apr;87:255-270. doi: 10.1016/j.neubiorev.2018.02.001. Epub 2018 Feb 8.
Background: PubMed 31514566Fasihpour B, Moayeri H, Shariat M, Keihanidoust Z, Effatpanah M, Khedmat L. Vitamin D deficiency in school-age Iranian children with attention-deficit/hyperactivity disorder (ADHD) symptoms: A critical comparison with healthy controls. Child Neuropsychol. 2020 May;26(4):460-474. doi: 10.1080/09297049.2019.1665638. Epub 2019 Sep 13.
Background: PubMed 24557746Fragoso YD, Stoney PN, McCaffery PJ. The evidence for a beneficial role of vitamin A in multiple sclerosis. CNS Drugs. 2014 Apr;28(4):291-9. doi: 10.1007/s40263-014-0148-4.
Background: PubMed 27183902Gallo EF, Posner J. Moving towards causality in attention-deficit hyperactivity disorder: overview of neural and genetic mechanisms. Lancet Psychiatry. 2016 Jun;3(6):555-67. doi: 10.1016/S2215-0366(16)00096-1. Epub 2016 May 13.
Background: PubMed 29220204Hinshaw SP. Attention Deficit Hyperactivity Disorder (ADHD): Controversy, Developmental Mechanisms, and Multiple Levels of Analysis. Annu Rev Clin Psychol. 2018 May 7;14:291-316. doi: 10.1146/annurev-clinpsy-050817-084917. Epub 2017 Dec 8.
Background: PubMed 28155214Lopes FM, da Motta LL, De Bastiani MA, Pfaffenseller B, Aguiar BW, de Souza LF, Zanatta G, Vargas DM, Schonhofen P, Londero GF, de Medeiros LM, Freire VN, Dafre AL, Castro MA, Parsons RB, Klamt F. RA Differentiation Enhances Dopaminergic Features, Changes Redox Parameters, and Increases Dopamine Transporter Dependency in 6-Hydroxydopamine-Induced Neurotoxicity in SH-SY5Y Cells. Neurotox Res. 2017 May;31(4):545-559. doi: 10.1007/s12640-016-9699-0. Epub 2017 Feb 2.
Background: PubMed 8052659McCaffery P, Drager UC. High levels of a retinoic acid-generating dehydrogenase in the meso-telencephalic dopamine system. Proc Natl Acad Sci U S A. 1994 Aug 2;91(16):7772-6. doi: 10.1073/pnas.91.16.7772.
Background: PubMed 27924679Mohammadpour N, Jazayeri S, Tehrani-Doost M, Djalali M, Hosseini M, Effatpanah M, Davari-Ashtiani R, Karami E. Effect of vitamin D supplementation as adjunctive therapy to methylphenidate on ADHD symptoms: A randomized, double blind, placebo-controlled trial. Nutr Neurosci. 2018 Apr;21(3):202-209. doi: 10.1080/1028415X.2016.1262097. Epub 2016 Dec 7.
Background: PubMed 30065237Moretti R, Morelli ME, Caruso P. Vitamin D in Neurological Diseases: A Rationale for a Pathogenic Impact. Int J Mol Sci. 2018 Jul 31;19(8):2245. doi: 10.3390/ijms19082245.
Individual participant dataSharing planned: No. Data is confidential during the study.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Li Chen, doctor contact

136 7762 0103 ext. +86

chenli2012@126.com

Li Chen, doctor study director

Children's Hospital of Chongqing Medical University

yu T Li, MS study chair

Children's Hospital of Chongqing Medical University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing vitamin AD and vitamin D in people with ADHD, run by Chen Li at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Li Chen, doctor (136 7762 0103 ext. +86, chenli2012@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt parent assessment scale (time frame: at baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04284059, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.