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

NCT ID: NCT04509401

Last Updated: 2022-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-11
• Study Completion Date: 2020-11-15

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Vitamin B 6 with Magnesium

Intervention Type: 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.

Control

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

Group Type: PLACEBO_COMPARATOR

placebo of vitamin B6 and magnesium

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

placebo of vitamin B6 and magnesium

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

-

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Dr. Fatema Ershad

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatema Ershad, MBBS

Role: PRINCIPAL_INVESTIGATOR

BSMMU (Recruiting)

Locations

Bangabandhu Sheikh Mujib Medical University

Dhaka, , Bangladesh

Countries

Bangladesh

Other Identifiers

BSMMU/2019/12342

Identifier Type: -

Identifier Source: org_study_id