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

NCT04509401 | Completed

• 1 other identifier: BSMMU/2019/12342
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Vitamin B6; Magnesium; Homovanillic acid; ADCL; ASD

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Study Arms (2)

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.

Drug: Vitamin B 6 with Magnesium

Control

PLACEBO COMPARATOR

Control group will receive oral placebo in the same manner, schedule and time frame.

Drug: placebo of vitamin B6 and magnesium

Interventions

Vitamin B 6 with Magnesium DRUG

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.

Interventional

placebo of vitamin B6 and magnesium DRUG

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

Control

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Interventions

Vitamin B 6; Magnesium

Intervention Hierarchy (Ancestors)

Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Fatema Ershad, MBBS

  BSMMU (Recruiting)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 12, 2020
• Study Start: January 11, 2020
• Primary Completion: November 15, 2020
• Study Completion: November 15, 2020
• Last Updated: February 17, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)