- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04509401
Effects of High Dose of Vitamin B6 With Magnesium in Children With Autism Spectrum Disorder
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Dhaka, Bangladesh, 1000
- Bangabandhu Sheikh Mujib Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Newly diagnosed patients of Autism Spectrum Disorder Co-morbid neurological disorder like irritability, hyperactivity with ASD
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Exclusion Criteria: Epilepsy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Interventional
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.
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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.
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Placebo Comparator: Control
Control group will receive oral placebo in the same manner, schedule and time frame.
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Patients of control group will receive oral placebo tablet in the same manner, schedule for 12 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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12 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Fatema Ershad, MBBS, BSMMU (Recruiting)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BSMMU/2019/12342
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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