Autism Spectrum DisorderTACASDNCT06623227
Effect of Increasing Total Antioxidant Capacity in Autism Spectrum Disorder
A study testing Vitamin E and C in people with Autism Spectrum Disorder, run by Rinvil Renaldi at 1 site in Indonesia.
Trial summary
This double-blind, randomized, controlled trial (RCT) has the aim to evaluating the effectiveness of increasing Total Antioxidant Capacity (TAC) as add-on intervention in two cohorts of patients with Autism Spectrum Disorder (ASD) who have received Risperidone (0.02-0.06 mg/KgBW) and Behavior Therapy as maintenance… Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Vitamin E and C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 28 Sep 2024to 30 Jun 2025
- Phase
- Interventional
- 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 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both parents or a legally authorized patient representative (LAR) must provide written informed consent. The parents and guardian must be able to understand and comply with the experimental protocol with a minimum of junior high school education.
- Parents earn no less than IDR 3,434,298 (South Sulawesi Province Minimum Wage for 2024).
- Subjects of both sexes, aged between 3-9 years old, may be included in the study.
- The subject must meet DSM-5 criteria for a primary diagnosis of Autism.
- Patients treated with Risperidone (0.02-0.06 mg/KgBW) are enrolled only if the treatment and dosage of these drugs has been constant for at least 2 months prior to enrollment in the trial and is kept constant throughout the 3-month duration of the trial.
- Patients undergoing any kind of behavioral intervention must have must have underwent the intervention at least 2 sessions prior to enrollment and the intervention must remain unchanged throughout the 3-month duration of the trial.
- Baseline Clinical Global Impression - Severity (CGI-S) score below 7.
- The patient is able to swallow the capsule or his/her parents are available to open it and administer immediately its content in a small quantity of juice or soft-drink.
Who cannot join
- Patients with organic disease and/or congenital malformation including known genetic syndromes for example, Rett syndrome, fragile-X syndrome, and Down Syndrome etc.).
- Patients with autism secondary to epileptic encephalopathy or with idiopathic autism co-morbid with seizures more frequent than one episode every 6 months despite ongoing anti epileptic drug therapy.
- Patients treated with anticoagulants.
- Patients with serious medical illnesses (chronic renal disease, severe liver disease, cardiovascular disorders, malignant tumors, HIV infection).
- Patients with a history of acute cerebrovascular episodes.
- Patients with a history of stomach bleeding or active peptic ulcer.
Show all 14Show fewer
- Patients with documented allergy, hypersensitivity or intolerance to one of the excipients of the experimental or comparative product.
- Patients have been consuming other antioxidants.
- Patients with active urinary tract infections.
- Patients with poor compliance and or no control back to the Hospital.
- Trial interruption criteria:
- Patients whose medical conditions require starting treatment with anticoagulants.
- Patients with severe medical conditions starting during the 3-month duration of the trial.
- Patients who undergo a change in psychopharmacological or behavioral treatment during the 3-month duration of the trial.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Doctoral Programme at Hasanuddin University
Makassar, South Sulawesi
About this study
Official title: Randomized, Placebo-controlled, Double-blind Study of Increasing Total Antioxidant Capacity with Vitamin E and C in Two Cohorts of Patients with Autism Spectrum Disorders
This double-blind, randomized, controlled trial (RCT) has the aim to evaluating the effectiveness of increasing Total Antioxidant Capacity (TAC) as add-on intervention in two cohorts of patients with Autism Spectrum Disorder (ASD) who have received Risperidone (0.02-0.06 mg/KgBW) and Behavior Therapy as maintenance therapy. Both groups will receive placebo pill or Vitamin E and C pill using randomization. Clinical Symptoms, Aberrant Behavior and Quality of Life in Children with ASD will be assessed after 12 weeks of treatment in this study. Primary outcome measures of efficacy is Aberrant Behavior Checklist- Irritability (ABC-Irritability) and Secondary outcome measures include Childhood Autism Rating Scale (CARS), Clinical Global Impression Scale - Improvement (CGI-I), The PedsQL and The WHOQOL BREF.
Read the detailed description
The continuation of ASD throughout life makes all efforts to optimize the abilities of children with ASD as early as possible so that their quality of life becomes better important. Management to improve current symptoms and overcome aberrant behavior in children with ASD generally focuses on behavioral intervention, psychotherapy and even pharmacotherapy, but the results are not satisfactory because it takes time, is expensive and unexpected side effects often occur after administering pharmacotherapy. On the other hand, research related to the role of oxidative stress has suggested a potential relationship between oxidative stress and autism pathophysiology that is not correlated with age and the underlying pathogenesis, but damage caused by oxidative stress will exacerbate dysfunction in children with ASD through chronic inflammatory responses, DNA and protein damage and mitochondrial superoxide production. Oxidative stress will influence the clinical symptoms and pathogenesis of ASD. Therefore, efforts to control the balance of oxidative stress to improve symptoms and neuropsychological deficits in patients with ASD are important. Lack of antioxidant capacity in children with ASD to neutralize and remove oxidants has been associated with the severity of clinical symptoms and aberrant behavior in children with ASD. Therefore, efforts to increase antioxidant capacity through providing antioxidants can offer a new strategy for dealing with accompanying symptoms in children with ASD.
Vitamin E and Vitamin C are non-enzymatic antioxidants which function to strengthen the work of enzymatic antioxidants in the oxidant-elimination, oxidation-reduction cycle process that occurs in the brain. Its includes in group of antioxidants which also referred as chain breaking. When used together with vitamin C which can function as a water-soluble antioxidant and other enzyme cofactors, reduced vitamin C can directly regenerate vitamin E which simultaneously undergoes oxidation to become ascorbate. Therefore, the use of vitamin C will be more effective when used together with vitamin E. Research has shown that administration with antioxidants such as vitamin E and vitamin C has a good effect on clinical symptoms and behavior in children with ASD.
In this randomized controlled trial (RCT), patients with Autism Spectrum Disorder (ASD) who have received Risperidone and Behavior Therapy as maintenance therapy will be randomly assigned to receive either a placebo or a combination of Vitamins E (150-200 IU per day) and C (100-200 mg per day) for a duration of 3 months. This study was designed to verify whether increasing the TAC using Vitamin E and C improves clinical symptoms, aberrant behaviors, and quality of life in children with ASD.
This study shall include 50 patients with ASD, aged 3-9 years old. The study design of this RCT was balanced to all of patients treated with maintenance therapy as usual, so that half of the patients will receive placebo, and the remaining half will receive Vitamin E and C during 3 months. The purpose is to observe whether the increase of TAC could improve the clinical symptoms, aberrant behavior and quality of life in ASD patients. In addition to clinical and psychometric parameters, TAC will be measured at baseline, after 6 weeks and 12 weeks, by collecting 30-60 ml of fresh urine, a general urinalysis examination to rule out acute urinary tract infections, The TAC examination is carried out when the urine pH is normal and measurement with a calorimetric kit with enzyme method, ABTS.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Placebo, Vitamin E and C
- Keywords
- Total antioxidant capacity, Autism, Clinical symptoms, Aberrant behavior, Quality of life, Vitamin E, Vitamin C
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Capsule contains substances that are safe, non-active, and commonly used in pharmaceuticals (microcrystalline cellulose) with an appropriate coloring dye and in the active arms, Vitamin E and C. Capsules can be opened and the content drunk or chewed, if children have difficulties with swallowing capsules
Vitamin E and CDietary supplement
Capsule Vitamin E (Natural Vitamin E, d-alpha tocopherol) 150 IU or 200 IU containing also Vitamin C 100 mg or 200 mg b.id depending on age. Capsules can be opened and the content drunk or chewed, if children have difficulties with swallowing capsules
| Study group | Role | What they receive |
|---|---|---|
| ASD Placebo | Active comparator | If the age is up to 4 years old:
• Risperidone (0.02-0.06 mg/KgBW) and Behavior Therapy as maintenance therapy and Capsule Placebo.
If age is above 4 years old:
• Risperidone (0.02-0.06 mg/KgBW) and Behavior Therapy as maintenance therapy and Capsule Placebo. Receives: Dietary Supplement: Placebo |
| ASD Active compound | Experimental | If the age is up to 4 years old:
• Risperidone (0.02-0.06 mg/KgBW) and Behavior Therapy as maintenance therapy and Capsul containing Vitamin E 150 IU and Vitamin C 100 mg.
If age is above 4 years old:
• Risperidone (0.02-0.06 mg/KgBW) and Behavior Therapy as maintenance therapy and Capsul containing Vitamin E 200 IU and Vitamin C 200 mg. Receives: Dietary Supplement: Vitamin E and C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aberrant Behavior Checklist - Irritability (ABC-I)
An instrument which is used by parents to measure aberrant behavior in children which consists of 15 assessment items with a scale of 0-3 to assess the level of severity. Score between 0-45 with interpretation if score \<20, mild; 20-40 moderate; \>40, severe irritability.
Measured: At 0, 6 and 12 weeks duration of trial
Secondary outcomes (4)
Childhood Autism Rating Scale (CARS)
CARS is an instrument for measuring the severity of signs and symptoms of ASD carried out by experienced clinicians. Score between 15-60 with interpretation if score \<30, non-autistic; 30-36.5 mild to moderate autism; 37-60, severe autism.
Measured: At 0, 6 and 12 weeks duration of trial
Clinical Global Impression Scale- Improvement (CGI-I)
a scale consisting of 7 assessment points used by clinicians to assess the severity of the patient\'s initial condition, patient improvement/worsening during follow-up and treatment side effects.
Measured: At 0, 6 and 12 weeks duration of trial
The Pediatric Quality of Life TM (The PedsQL)
An instrument for assessing the quality of life in children related to health conditions, through self-assessment and/or parental observation, which is assessed based on conditions during the last 1 month.
Measured: At 0, 6 and 12 weeks duration of trial
WHOQOL-BREF
An instrument for assessing parents\' quality of life through self-assessment. The WHOQOL is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale.
Measured: At 0, 6 and 12 weeks duration of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start28 Sep 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each patients treated with Risperidone and Behavior Therapy as maintanence therapy will divided into a controled group which receive plasebo and the other as intervention group which received Vitamin E (150-200 IU/d) and C (100-200 mg/d) for 3 months. Patients are assessed at T0, T6 and T12 wk. Administration of active compound and placebo is in double-blind.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rinvil Renaldi
- Sponsor type
- University, hospital or other
- Collaborators
- University of Modena and Reggio Emilia, Universitas Indonesia, RSUP Dr. Wahidin Sudirohusodo
- Responsible party
- Sponsor-investigator, Rinvil Renaldi, Hasanuddin University
- Investigators
- Rinvil Renaldi, MD, Principal investigator, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623227
- Sponsor's protocol ID
- TAC_Study_ASD
- Acronym
- TACASD
- Status last verified
- Sep 2024
- First submitted
- 30 Sep 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Persico AM, Arango C, Buitelaar JK, Correll CU, Glennon JC, Hoekstra PJ, Moreno C, Vitiello B, Vorstman J, Zuddas A; European Child and Adolescent Clinical Psychopharmacology Network. Unmet needs in paediatric psychopharmacology: Present scenario and future perspectives. Eur Neuropsychopharmacol. 2015 Oct;25(10):1513-31. doi: 10.1016/j.euroneuro.2015.06.009. Epub 2015 Jun 20.
PubMed 26166453Adams JB, Audhya T, McDonough-Means S, Rubin RA, Quig D, Geis E, Gehn E, Loresto M, Mitchell J, Atwood S, Barnhouse S, Lee W. Effect of a vitamin/mineral supplement on children and adults with autism. BMC Pediatr. 2011 Dec 12;11:111. doi: 10.1186/1471-2431-11-111.
PubMed 22151477Zambrelli E, Lividini A, Spadavecchia S, Turner K, Canevini MP. Effects of Supplementation With Antioxidant Agents on Sleep in Autism Spectrum Disorder: A Review. Front Psychiatry. 2021 Jun 28;12:689277. doi: 10.3389/fpsyt.2021.689277. eCollection 2021.
PubMed 34262494Wang L, Wang B, Wu C, Wang J, Sun M. Autism Spectrum Disorder: Neurodevelopmental Risk Factors, Biological Mechanism, and Precision Therapy. Int J Mol Sci. 2023 Jan 17;24(3):1819. doi: 10.3390/ijms24031819.
PubMed 36768153Vargason T, Kruger U, Roth E, Delhey LM, Tippett M, Rose S, Bennuri SC, Slattery JC, Melnyk S, James SJ, Frye RE, Hahn J. Comparison of Three Clinical Trial Treatments for Autism Spectrum Disorder Through Multivariate Analysis of Changes in Metabolic Profiles and Adaptive Behavior. Front Cell Neurosci. 2018 Dec 19;12:503. doi: 10.3389/fncel.2018.00503. eCollection 2018.
PubMed 30618645Traber MG. Vitamin E: necessary nutrient for neural development and cognitive function. Proc Nutr Soc. 2021 Aug;80(3):319-326. doi: 10.1017/S0029665121000914. Epub 2021 Apr 26.
PubMed 33896432Teleanu DM, Niculescu AG, Lungu II, Radu CI, Vladacenco O, Roza E, Costachescu B, Grumezescu AM, Teleanu RI. An Overview of Oxidative Stress, Neuroinflammation, and Neurodegenerative Diseases. Int J Mol Sci. 2022 May 25;23(11):5938. doi: 10.3390/ijms23115938.
PubMed 35682615Silvestrini A, Meucci E, Ricerca BM, Mancini A. Total Antioxidant Capacity: Biochemical Aspects and Clinical Significance. Int J Mol Sci. 2023 Jul 1;24(13):10978. doi: 10.3390/ijms241310978.
PubMed 37446156Pangrazzi L, Balasco L, Bozzi Y. Natural Antioxidants: A Novel Therapeutic Approach to Autism Spectrum Disorders? Antioxidants (Basel). 2020 Nov 26;9(12):1186. doi: 10.3390/antiox9121186.
PubMed 33256243Hughes HK, R J Moreno, Ashwood P. Innate immune dysfunction and neuroinflammation in autism spectrum disorder (ASD). Brain Behav Immun. 2023 Feb;108:245-254. doi: 10.1016/j.bbi.2022.12.001. Epub 2022 Dec 6.
PubMed 36494048Liu X, Lin J, Zhang H, Khan NU, Zhang J, Tang X, Cao X, Shen L. Oxidative Stress in Autism Spectrum Disorder-Current Progress of Mechanisms and Biomarkers. Front Psychiatry. 2022 Mar 1;13:813304. doi: 10.3389/fpsyt.2022.813304. eCollection 2022.
PubMed 35299821Logan SL, Carpenter L, Leslie RS, Garrett-Mayer E, Hunt KJ, Charles J, Nicholas JS. Aberrant Behaviors and Co-occurring Conditions as Predictors of Psychotropic Polypharmacy among Children with Autism Spectrum Disorders. J Child Adolesc Psychopharmacol. 2015 May;25(4):323-36. doi: 10.1089/cap.2013.0119. Epub 2015 Apr 28.
PubMed 25919445Lee KH, Cha M, Lee BH. Neuroprotective Effect of Antioxidants in the Brain. Int J Mol Sci. 2020 Sep 28;21(19):7152. doi: 10.3390/ijms21197152.
PubMed 32998277Imataka G, Yui K, Shiko Y, Kawasaki Y, Sasaki H, Shiroki R, Yoshihara S. Urinary and Plasma Antioxidants in Behavioral Symptoms of Individuals With Autism Spectrum Disorder. Front Psychiatry. 2021 Sep 3;12:684445. doi: 10.3389/fpsyt.2021.684445. eCollection 2021.
PubMed 34539458Goel R, Hong JS, Findling RL, Ji NY. An update on pharmacotherapy of autism spectrum disorder in children and adolescents. Int Rev Psychiatry. 2018 Feb;30(1):78-95. doi: 10.1080/09540261.2018.1458706. Epub 2018 Apr 25.
PubMed 29693461
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled, Double-blind Study of Increasing Total Antioxidant Capacity with Vitamin E and C in Two Cohorts of Patients with Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT06623227
- Acronym / sponsor ID
- TACASD / TAC_Study_ASD
- Conditions
- Autism Spectrum Disorder
- Keywords
- Total antioxidant capacity, Autism, Clinical symptoms, Aberrant behavior, Quality of life, Vitamin E, Vitamin C
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rinvil RenaldiUniversity, hospital or other
- Collaborators
- University of Modena and Reggio Emilia, Universitas Indonesia, RSUP Dr. Wahidin Sudirohusodo
- Study start
- 28 Sep 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 2 Oct 2024 (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.
This double-blind, randomized, controlled trial (RCT) has the aim to evaluating the effectiveness of increasing Total Antioxidant Capacity (TAC) as add-on intervention in two cohorts of patients with Autism Spectrum Disorder (ASD) who have received Risperidone (0.02-0.06 mg/KgBW) and Behavior Therapy as maintenance therapy. Both groups will receive placebo pill or Vitamin E and C pill using randomization. Clinical Symptoms, Aberrant Behavior and Quality of Life in Children with ASD will be assessed after 12 weeks of treatment in this study. Primary outcome measures of efficacy is Aberrant Behavior Checklist- Irritability (ABC-Irritability) and Secondary outcome measures include Childhood Autism Rating Scale (CARS), Clinical Global Impression Scale - Improvement (CGI-I), The PedsQL and The WHOQOL BREF.
Detailed description
The continuation of ASD throughout life makes all efforts to optimize the abilities of children with ASD as early as possible so that their quality of life becomes better important. Management to improve current symptoms and overcome aberrant behavior in children with ASD generally focuses on behavioral intervention, psychotherapy and even pharmacotherapy, but the results are not satisfactory because it takes time, is expensive and unexpected side effects often occur after administering pharmacotherapy. On the other hand, research related to the role of oxidative stress has suggested a potential relationship between oxidative stress and autism pathophysiology that is not correlated with age and the underlying pathogenesis, but damage caused by oxidative stress will exacerbate dysfunction in children with ASD through chronic inflammatory responses, DNA and protein damage and mitochondrial superoxide production. Oxidative stress will influence the clinical symptoms and pathogenesis of ASD. Therefore, efforts to control the balance of oxidative stress to improve symptoms and neuropsychological deficits in patients with ASD are important. Lack of antioxidant capacity in children with ASD to neutralize and remove oxidants has been associated with the severity of clinical symptoms and aberrant behavior in children with ASD. Therefore, efforts to increase antioxidant capacity through providing antioxidants can offer a new strategy for dealing with accompanying symptoms in children with ASD.
Vitamin E and Vitamin C are non-enzymatic antioxidants which function to strengthen the work of enzymatic antioxidants in the oxidant-elimination, oxidation-reduction cycle process that occurs in the brain. Its includes in group of antioxidants which also referred as chain breaking. When used together with vitamin C which can function as a water-soluble antioxidant and other enzyme cofactors, reduced vitamin C can directly regenerate vitamin E which simultaneously undergoes oxidation to become ascorbate. Therefore, the use of vitamin C will be more effective when used together with vitamin E. Research has shown that administration with antioxidants such as vitamin E and vitamin C has a good effect on clinical symptoms and behavior in children with ASD.
In this randomized controlled trial (RCT), patients with Autism Spectrum Disorder (ASD) who have received Risperidone and Behavior Therapy as maintenance therapy will be randomly assigned to receive either a placebo or a combination of Vitamins E (150-200 IU per day) and C (100-200 mg per day) for a duration of 3 months. This study was designed to verify whether increasing the TAC using Vitamin E and C improves clinical symptoms, aberrant behaviors, and quality of life in children with ASD.
This study shall include 50 patients with ASD, aged 3-9 years old. The study design of this RCT was balanced to all of patients treated with maintenance therapy as usual, so that half of the patients will receive placebo, and the remaining half will receive Vitamin E and C during 3 months. The purpose is to observe whether the increase of TAC could improve the clinical symptoms, aberrant behavior and quality of life in ASD patients. In addition to clinical and psychometric parameters, TAC will be measured at baseline, after 6 weeks and 12 weeks, by collecting 30-60 ml of fresh urine, a general urinalysis examination to rule out acute urinary tract infections, The TAC examination is carried out when the urine pH is normal and measurement with a calorimetric kit with enzyme method, ABTS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Each patients treated with Risperidone and Behavior Therapy as maintanence therapy will divided into a controled group which receive plasebo and the other as intervention group which received Vitamin E (150-200 IU/d) and C (100-200 mg/d) for 3 months. Patients are assessed at T0, T6 and T12 wk. Administration of active compound and placebo is in double-blind.
| Arm | Type | Receives |
|---|---|---|
| ASD Placebo | Active comparator | Dietary Supplement: PlaceboIf the age is up to 4 years old: • Risperidone (0.02-0.06 mg/KgBW) and Behavior Therapy as maintenance therapy and Capsule Placebo. If age is above 4 years old: • Risperidone (0.02-0.06 mg/KgBW) and Behavior Therapy as maintenance therapy and Capsule Placebo. |
| ASD Active compound | Experimental | Dietary Supplement: Vitamin E and CIf the age is up to 4 years old: • Risperidone (0.02-0.06 mg/KgBW) and Behavior Therapy as maintenance therapy and Capsul containing Vitamin E 150 IU and Vitamin C 100 mg. If age is above 4 years old: • Risperidone (0.02-0.06 mg/KgBW) and Behavior Therapy as maintenance therapy and Capsul containing Vitamin E 200 IU and Vitamin C 200 mg. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Both parents or a legally authorized patient representative (LAR) must provide written informed consent. The parents and guardian must be able to understand and comply with the experimental protocol with a minimum of junior high school education.
- Parents earn no less than IDR 3,434,298 (South Sulawesi Province Minimum Wage for 2024).
- Subjects of both sexes, aged between 3-9 years old, may be included in the study.
- The subject must meet DSM-5 criteria for a primary diagnosis of Autism.
- Patients treated with Risperidone (0.02-0.06 mg/KgBW) are enrolled only if the treatment and dosage of these drugs has been constant for at least 2 months prior to enrollment in the trial and is kept constant throughout the 3-month duration of the trial.
Key exclusion criteria (14 listed)
- Patients with organic disease and/or congenital malformation including known genetic syndromes for example, Rett syndrome, fragile-X syndrome, and Down Syndrome etc.).
- Patients with autism secondary to epileptic encephalopathy or with idiopathic autism co-morbid with seizures more frequent than one episode every 6 months despite ongoing anti epileptic drug therapy.
- Patients treated with anticoagulants.
- Patients with serious medical illnesses (chronic renal disease, severe liver disease, cardiovascular disorders, malignant tumors, HIV infection).
- Patients with a history of acute cerebrovascular episodes.
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 |
|---|---|---|
| PlaceboCapsule contains substances that are safe, non-active, and commonly used in pharmaceuticals (microcrystalline cellulose) with an appropriate coloring dye and in the active arms, Vitamin E and C. Capsules can be opened and the content drunk or chewed, if children have difficulties with swallowing capsules | Dietary supplement | ASD Placebo |
| Vitamin E and CCapsule Vitamin E (Natural Vitamin E, d-alpha tocopherol) 150 IU or 200 IU containing also Vitamin C 100 mg or 200 mg b.id depending on age. Capsules can be opened and the content drunk or chewed, if children have difficulties with swallowing capsules | Dietary supplement | ASD Active compound |
Primary outcome
Aberrant Behavior Checklist - Irritability (ABC-I)
Time frame: At 0, 6 and 12 weeks duration of trial
An instrument which is used by parents to measure aberrant behavior in children which consists of 15 assessment items with a scale of 0-3 to assess the level of severity. Score between 0-45 with interpretation if score \<20, mild; 20-40 moderate; \>40, severe irritability.
4 secondary outcomes
Childhood Autism Rating Scale (CARS)
Time frame: At 0, 6 and 12 weeks duration of trial
Clinical Global Impression Scale- Improvement (CGI-I)
Time frame: At 0, 6 and 12 weeks duration of trial
The Pediatric Quality of Life TM (The PedsQL)
Time frame: At 0, 6 and 12 weeks duration of trial
WHOQOL-BREF
Time frame: At 0, 6 and 12 weeks duration of trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Background: PubMed 26166453Persico AM, Arango C, Buitelaar JK, Correll CU, Glennon JC, Hoekstra PJ, Moreno C, Vitiello B, Vorstman J, Zuddas A; European Child and Adolescent Clinical Psychopharmacology Network. Unmet needs in paediatric psychopharmacology: Present scenario and future perspectives. Eur Neuropsychopharmacol. 2015 Oct;25(10):1513-31. doi: 10.1016/j.euroneuro.2015.06.009. Epub 2015 Jun 20.
- Background: PubMed 22151477Adams JB, Audhya T, McDonough-Means S, Rubin RA, Quig D, Geis E, Gehn E, Loresto M, Mitchell J, Atwood S, Barnhouse S, Lee W. Effect of a vitamin/mineral supplement on children and adults with autism. BMC Pediatr. 2011 Dec 12;11:111. doi: 10.1186/1471-2431-11-111.
- Background: PubMed 34262494Zambrelli E, Lividini A, Spadavecchia S, Turner K, Canevini MP. Effects of Supplementation With Antioxidant Agents on Sleep in Autism Spectrum Disorder: A Review. Front Psychiatry. 2021 Jun 28;12:689277. doi: 10.3389/fpsyt.2021.689277. eCollection 2021.
- Background: PubMed 36768153Wang L, Wang B, Wu C, Wang J, Sun M. Autism Spectrum Disorder: Neurodevelopmental Risk Factors, Biological Mechanism, and Precision Therapy. Int J Mol Sci. 2023 Jan 17;24(3):1819. doi: 10.3390/ijms24031819.
- Background: PubMed 30618645Vargason T, Kruger U, Roth E, Delhey LM, Tippett M, Rose S, Bennuri SC, Slattery JC, Melnyk S, James SJ, Frye RE, Hahn J. Comparison of Three Clinical Trial Treatments for Autism Spectrum Disorder Through Multivariate Analysis of Changes in Metabolic Profiles and Adaptive Behavior. Front Cell Neurosci. 2018 Dec 19;12:503. doi: 10.3389/fncel.2018.00503. eCollection 2018.
- Background: PubMed 33896432Traber MG. Vitamin E: necessary nutrient for neural development and cognitive function. Proc Nutr Soc. 2021 Aug;80(3):319-326. doi: 10.1017/S0029665121000914. Epub 2021 Apr 26.
- Background: PubMed 35682615Teleanu DM, Niculescu AG, Lungu II, Radu CI, Vladacenco O, Roza E, Costachescu B, Grumezescu AM, Teleanu RI. An Overview of Oxidative Stress, Neuroinflammation, and Neurodegenerative Diseases. Int J Mol Sci. 2022 May 25;23(11):5938. doi: 10.3390/ijms23115938.
- Background: PubMed 37446156Silvestrini A, Meucci E, Ricerca BM, Mancini A. Total Antioxidant Capacity: Biochemical Aspects and Clinical Significance. Int J Mol Sci. 2023 Jul 1;24(13):10978. doi: 10.3390/ijms241310978.
- Background: PubMed 33256243Pangrazzi L, Balasco L, Bozzi Y. Natural Antioxidants: A Novel Therapeutic Approach to Autism Spectrum Disorders? Antioxidants (Basel). 2020 Nov 26;9(12):1186. doi: 10.3390/antiox9121186.
- Background: PubMed 36494048Hughes HK, R J Moreno, Ashwood P. Innate immune dysfunction and neuroinflammation in autism spectrum disorder (ASD). Brain Behav Immun. 2023 Feb;108:245-254. doi: 10.1016/j.bbi.2022.12.001. Epub 2022 Dec 6.
- Background: PubMed 35299821Liu X, Lin J, Zhang H, Khan NU, Zhang J, Tang X, Cao X, Shen L. Oxidative Stress in Autism Spectrum Disorder-Current Progress of Mechanisms and Biomarkers. Front Psychiatry. 2022 Mar 1;13:813304. doi: 10.3389/fpsyt.2022.813304. eCollection 2022.
- Background: PubMed 25919445Logan SL, Carpenter L, Leslie RS, Garrett-Mayer E, Hunt KJ, Charles J, Nicholas JS. Aberrant Behaviors and Co-occurring Conditions as Predictors of Psychotropic Polypharmacy among Children with Autism Spectrum Disorders. J Child Adolesc Psychopharmacol. 2015 May;25(4):323-36. doi: 10.1089/cap.2013.0119. Epub 2015 Apr 28.
- Individual participant dataSharing planned: No
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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.
Rinvil Renaldi, MD principal investigator
Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin E and C in people with Autism Spectrum Disorder, run by Rinvil Renaldi at 1 site in Indonesia.
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 8 inclusion and 14 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 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aberrant Behavior Checklist - Irritability (ABC-I) (time frame: At 0, 6 and 12 weeks duration of trial). 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 NCT06623227, which also lists 24 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 4 Oct 2024.