Effects of High Dose of Vitamin B6 With Magnesium in Children With Autism Spectrum Disorder
Condition: ASD
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

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.
    

Intervention name(s): Vitamin B 6 with Magnesium; placebo of vitamin B6 and magnesium
Intervention type(s): Drug; Drug
Intervention description(s): 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.; Patients of control group will receive oral placebo tablet in the same manner, schedule for 12 weeks.
Intervention MeSH terms: Vitamins; Vitamin B 6; Pyridoxal; Pyridoxine; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vitamin B6; Magnesium; Homovanillic acid; ADCL; ASD