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Effects of High Dose of Vitamin B6 With Magnesium in Children With Autism Spectrum Disorder

NCT04509401 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-02-17

No results posted yet for this study

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.

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.

Conditions

  • ASD

Interventions

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.

DRUG

placebo of vitamin B6 and magnesium

Patients of control group will receive oral placebo tablet in the same manner, schedule for 12 weeks.

Sponsors & Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Principal Investigators

  • Fatema Ershad, MBBS · BSMMU (Recruiting)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-11
Primary Completion
2020-11-15
Completion
2020-11-15

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04509401 on ClinicalTrials.gov