Effects of High Dose of Vitamin B6 With Magnesium in Children With Autism Spectrum Disorder
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|ClinicalTrials.gov Identifier: NCT04509401|
Recruitment Status : Completed
First Posted : August 12, 2020
Last Update Posted : February 17, 2022
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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.
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|ASD||Drug: Vitamin B 6 with Magnesium Drug: placebo of vitamin B6 and magnesium||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||January 11, 2020|
|Actual Primary Completion Date :||November 15, 2020|
|Actual Study Completion Date :||November 15, 2020|
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.
Drug: Vitamin B 6 with Magnesium
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 Comparator: Control
Control group will receive oral placebo in the same manner, schedule and time frame.
Drug: placebo of vitamin B6 and magnesium
Patients of control group will receive oral placebo tablet in the same manner, schedule for 12 weeks.
- 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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|Ages Eligible for Study:||2 Years to 8 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Inclusion Criteria: Newly diagnosed patients of Autism Spectrum Disorder Co-morbid neurological disorder like irritability, hyperactivity with ASD
Exclusion Criteria: Epilepsy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04509401
|Bangabandhu Sheikh Mujib Medical University|
|Dhaka, Bangladesh, 1000|
|Principal Investigator:||Fatema Ershad, MBBS||BSMMU (Recruiting)|
|Responsible Party:||Dr. Fatema Ershad, Principal Investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh|
|Other Study ID Numbers:||
|First Posted:||August 12, 2020 Key Record Dates|
|Last Update Posted:||February 17, 2022|
|Last Verified:||February 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Vitamin B 6
Vitamin B Complex
Physiological Effects of Drugs