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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04509401
Recruitment Status : Completed
First Posted : August 12, 2020
Last Update Posted : February 17, 2022
Sponsor:
Information provided by (Responsible Party):
Dr. Fatema Ershad, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study Description
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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.


Condition or disease Intervention/treatment Phase
ASD Drug: Vitamin B 6 with Magnesium Drug: placebo of vitamin B6 and magnesium Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 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.


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 12 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Bangladesh
Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh, 1000
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
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Principal Investigator: Fatema Ershad, MBBS BSMMU (Recruiting)
More Information
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Responsible Party: Dr. Fatema Ershad, Principal Investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT04509401    
Other Study ID Numbers: BSMMU/2019/12342
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Fatema Ershad, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:
Vitamin B6
Magnesium
Homovanillic acid
ADCL
ASD
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Vitamins
Vitamin B 6
 Pyridoxal
Pyridoxine
Vitamin B Complex
Micronutrients
Physiological Effects of Drugs