ASDNCT04509401
Effects of High Dose of Vitamin B6 With Magnesium in Children With Autism Spectrum Disorder
A study testing Vitamin B 6 with Magnesium in people with ASD, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
Title: The Neurobehavioral and Biochemical Effects of High Does of Vitamin B6 with Magnesium in Children with Autism spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Study. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- ASD
- What is being tested?
- Vitamin B 6 with Magnesium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteBangladesh
- Study dates
- 11 Jan 2020to 15 Nov 2020
- 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 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria: Newly diagnosed patients of Autism Spectrum Disorder Co-morbid neurological disorder like irritability, hyperactivity with ASD
-
Exclusion Criteria: Epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Neurobehavioral and Biochemical Effects of High Dose of Vitamin B6 With Magnesium in Children With Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Study
Title:
The Neurobehavioral and Biochemical Effects of High Does of Vitamin B6 with Magnesium in Children with Autism spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Study.
Read more
Purpose of the Study:
This study aims to examine the effect of higher doses of vitamin B6-magnesium combination in modification of urinary homovanillic acid excretion and improving behavioral sign symptoms in a newly diagnosed autistic children.
Method:
This study will be a randomized,double blind placebo controlled trial to assess the effects of high dose of vitamin B6 with magnesium upon autistic children. This study will be conducted in the Department of Pharmacology and Institute of Pediatric Neurodisorder and Autism (IPNA) in between July 2019 to July 2020. A total 66 newly diagnosed autistic children will be selected according to inclusion and exclusion criteria. The patients will be divided randomly into 2 groups: Intervention group and Control group. Intervention group will consist of 33 patients who will receive vitamin B6-magnesium along with standard care of treatment for three months. Vitamin B6 will be given 150 mg for ages 2-3 years, 200 mg for ages 4-6 years, 300 mg for ages 7-8 years and Magnesium will be given 50 mg 2-4 years, 100 mg for ages 4-8 years. Control group consist of 33 patients who will receive placebo in the same manners along with standard care of treatment for three months. To see the effects of Vitamin B6 and Magnesium, Autism Spectrum Disorder would be assessed by Autism Diagnostic Checklist (ADCL) at baseline and three months after intervention. Urinary homovanillic acid level would also be performed at baseline and three months after intervention.
Ethical consideration:
The study will follow the principles of the Declaration of Helsinki and of the World Medical Assembly. Parents of the patient will be informed about the study in easy language and then informed written consent will be taken. This study has no potential risk to the patients. Confidentiality will be strictly maintained.
Read the detailed description
Autism spectrum Disorder is a complex neuro- developmental, incurable disease with lifelong impacts.Epidemiological studies have shown a rapid increase in the prevalence of ASD throughout the world including Bangladesh. The World Health Organization (WHO) estimated every 1 in 160 children has an autism spectrum disorder. Various environmental, genetic ,biochemical, metabolic factors are presumed to be involved in the etiology of ASD. Researchers found Vitamin B6 with Magnesium has the potential effects to alleviate the core symptoms of autism. A possible association higher doses of vitamin B6-Magnesium supplementation may reduce biochemical abnormalities e.g. reduction of urinary excretion of homovanillic acid and improve neurobehavioral symptoms.Therefore the present study has been designed to assess the effects of high dose of vitamin B6 with magnesium along with standard care of treatment upon ASD patients. The study would be randomized, double blind placebo controlled trial to be conducted in the Department of Pharmacology and the Institute of Pediatric Neurodisoder and Autism(IPNA), BSMMU in between July 2019 to July 2020. A total 66 newly diagnosed ASD patients will be selected according to inclusion and exclusion criteria. The patients will be divided randomly into 2 groups: intervention and control. Intervention group would consist of 33 patients who wlill receive high dose of vitamin B6 with magnesium orally for three months. Vitamin B6 will be given 50 mg for 2- 3 years, 200 mg for ages 4-6 years, 300 mg for ages 7-8 years and Magnesium will be given 50 mg for 2-3 years, 100 mg for ages 4-8 years. Control group would also consist of 33 patients who will receive placebo in the same manners along with standard care of treatment for three months. Comparison between the two groups will be performed through urinary homovanillic acid estimation at baseline and three months after the intervention. Neurobehavioral status will be assess by Autism Diagnostic Checklist (ADCL) at baseline and after three months of intervention. Data would be analyzed by Scientific Package for Social Science and represented by tables and figures as applicable. Significance level would be set at 0.05, 0.01 and 0.001. Patients data will be recorded in a predetermined data sheet. Parents of the patient will be informed about the study in easy language and then written informed consent will be taken.This study has no potential risk to the patients.
- Conditions
- ASD
- Being tested
- Vitamin B 6 with Magnesium, placebo of vitamin B6 and magnesium
- Keywords
- Vitamin B6, Magnesium, Homovanillic acid, ADCL, ASD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B 6 with MagnesiumDrug
Patients of intervention group will receive high dose of vitamin B6 with magnesium. This group will receive high dose of vitamin B6 with magnesium orally for 12 weeks.
placebo of vitamin B6 and magnesiumDrug
Patients of control group will receive oral placebo tablet in the same manner, schedule for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Active comparator | High dose of Vitamin B6 with Magnesium. Vitamin B6 will be given orally 150 mg for ages 2-3 years, 200 mg for ages 4-6 years,300 mg for ages 7-8 years and Magnesium will be given orally 50 mg for 2-3 years, 100 mg for ages 7-8 years for three months. Receives: Drug: Vitamin B 6 with Magnesium |
| Control | Placebo comparator | Control group will receive oral placebo in the same manner, schedule and time frame. Receives: Drug: placebo of vitamin B6 and magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the urinary homovanillic acid Conc in µgm/mg of creatinine in Vitamin B6 with magnesium treated autistic children pre and post supplementation of Vitamin B6 and Magnesium.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start11 Jan 2020
- Primary completion15 Nov 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASDStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fatema Ershad, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Fatema Ershad, MBBS, Principal investigator, BSMMU (Recruiting)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509401
- Sponsor's protocol ID
- BSMMU/2019/12342
- Status last verified
- Feb 2022
- First submitted
- 29 Jul 2020
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neurobehavioral and Biochemical Effects of High Dose of Vitamin B6 With Magnesium in Children With Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT04509401
- Acronym / sponsor ID
- BSMMU/2019/12342
- Conditions
- ASD
- Keywords
- Vitamin B6, Magnesium, Homovanillic acid, ADCL, ASD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 11 Jan 2020 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 12 Aug 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.
Title:
The Neurobehavioral and Biochemical Effects of High Does of Vitamin B6 with Magnesium in Children with Autism spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Study.
Purpose of the Study:
This study aims to examine the effect of higher doses of vitamin B6-magnesium combination in modification of urinary homovanillic acid excretion and improving behavioral sign symptoms in a newly diagnosed autistic children.
Method:
This study will be a randomized,double blind placebo controlled trial to assess the effects of high dose of vitamin B6 with magnesium upon autistic children. This study will be conducted in the Department of Pharmacology and Institute of Pediatric Neurodisorder and Autism (IPNA) in between July 2019 to July 2020. A total 66 newly diagnosed autistic children will be selected according to inclusion and exclusion criteria. The patients will be divided randomly into 2 groups: Intervention group and Control group. Intervention group will consist of 33 patients who will receive vitamin B6-magnesium along with standard care of treatment for three months. Vitamin B6 will be given 150 mg for ages 2-3 years, 200 mg for ages 4-6 years, 300 mg for ages 7-8 years and Magnesium will be given 50 mg 2-4 years, 100 mg for ages 4-8 years. Control group consist of 33 patients who will receive placebo in the same manners along with standard care of treatment for three months. To see the effects of Vitamin B6 and Magnesium, Autism Spectrum Disorder would be assessed by Autism Diagnostic Checklist (ADCL) at baseline and three months after intervention. Urinary homovanillic acid level would also be performed at baseline and three months after intervention.
Ethical consideration:
The study will follow the principles of the Declaration of Helsinki and of the World Medical Assembly. Parents of the patient will be informed about the study in easy language and then informed written consent will be taken. This study has no potential risk to the patients. Confidentiality will be strictly maintained.
Detailed description
Autism spectrum Disorder is a complex neuro- developmental, incurable disease with lifelong impacts.Epidemiological studies have shown a rapid increase in the prevalence of ASD throughout the world including Bangladesh. The World Health Organization (WHO) estimated every 1 in 160 children has an autism spectrum disorder. Various environmental, genetic ,biochemical, metabolic factors are presumed to be involved in the etiology of ASD. Researchers found Vitamin B6 with Magnesium has the potential effects to alleviate the core symptoms of autism. A possible association higher doses of vitamin B6-Magnesium supplementation may reduce biochemical abnormalities e.g. reduction of urinary excretion of homovanillic acid and improve neurobehavioral symptoms.Therefore the present study has been designed to assess the effects of high dose of vitamin B6 with magnesium along with standard care of treatment upon ASD patients. The study would be randomized, double blind placebo controlled trial to be conducted in the Department of Pharmacology and the Institute of Pediatric Neurodisoder and Autism(IPNA), BSMMU in between July 2019 to July 2020. A total 66 newly diagnosed ASD patients will be selected according to inclusion and exclusion criteria. The patients will be divided randomly into 2 groups: intervention and control. Intervention group would consist of 33 patients who wlill receive high dose of vitamin B6 with magnesium orally for three months. Vitamin B6 will be given 50 mg for 2- 3 years, 200 mg for ages 4-6 years, 300 mg for ages 7-8 years and Magnesium will be given 50 mg for 2-3 years, 100 mg for ages 4-8 years. Control group would also consist of 33 patients who will receive placebo in the same manners along with standard care of treatment for three months. Comparison between the two groups will be performed through urinary homovanillic acid estimation at baseline and three months after the intervention. Neurobehavioral status will be assess by Autism Diagnostic Checklist (ADCL) at baseline and after three months of intervention. Data would be analyzed by Scientific Package for Social Science and represented by tables and figures as applicable. Significance level would be set at 0.05, 0.01 and 0.001. Patients data will be recorded in a predetermined data sheet. Parents of the patient will be informed about the study in easy language and then written informed consent will be taken.This study has no potential risk to the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Active comparator | Drug: Vitamin B 6 with MagnesiumHigh dose of Vitamin B6 with Magnesium. Vitamin B6 will be given orally 150 mg for ages 2-3 years, 200 mg for ages 4-6 years,300 mg for ages 7-8 years and Magnesium will be given orally 50 mg for 2-3 years, 100 mg for ages 7-8 years for three months. |
| Control | Placebo comparator | Drug: placebo of vitamin B6 and magnesiumControl group will receive oral placebo in the same manner, schedule and time frame. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Vitamin B 6 with MagnesiumPatients of intervention group will receive high dose of vitamin B6 with magnesium. This group will receive high dose of vitamin B6 with magnesium orally for 12 weeks. | Drug | Interventional |
| placebo of vitamin B6 and magnesiumPatients of control group will receive oral placebo tablet in the same manner, schedule for 12 weeks. | Drug | Control |
Primary outcome
To measure the urinary homovanillic acid Conc in µgm/mg of creatinine in Vitamin B6 with magnesium treated autistic children pre and post supplementation of Vitamin B6 and Magnesium.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- 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.
Fatema Ershad, MBBS principal investigator
BSMMU (Recruiting)
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 B 6 with Magnesium in people with ASD, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 17 Feb 2022. 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 Bangladesh. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To measure the urinary homovanillic acid Conc in µgm/mg of creatinine in Vitamin B6 with magnesium treated autistic children pre and post supplementation of Vitamin B6 and Magnesium. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2022.