Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients

Study Overview
=================
Brief Summary
-----------------
To determine whether Vitamin B6 and Magnesium improve neurobehavioral status in terms of General observation, Cognitive working, Socialization, Communication and Sensory Dysfunction in patient with Autism Spectrum Disorder.

Official Title
-----------------
Vitamin B6 and Magnesium on Neurobehavioral Status of Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Study

Conditions
-----------------
Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Combination Product: Magnesium and Vitamin B6


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children between 2 to 12 years of age suspected ASD assessed by DSM-5 and ADCL tool Each patient will be free of psychoactive medication for atleast 3 months prior to the entry into the trial Newly diagnosed patient Co-morbid neurological disorder like hyperactivity Exclusion Criteria: Patients with chronic diseases or any known metabolic or hormonal diseases Patients with any known chromosomal or genetic syndromes Patients unable to give informed consent Patients unable to travel to clinical visits or non co-operative

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnesium-Vitamin B6<br>Magnesium (50mg) for ages 1-3 years (100mg) for ages 4-8 years (200mg) for ages 9-12 years Vitamin B6 (25mg) for ages 1-3 years (50mg) for ages 4-8 years (100mg) for ages 9-12years | Combination Product: Magnesium and Vitamin B6<br>* Magnesium and Vitamin B6 will be given to the enrolled patients for 3 months<br>|
| Placebo Comparator: Placebo<br>Magnesium (50mg) for ages 1-3 years (100mg) for ages 4-8 years (200mg) for ages 9-12 years Vitamin B6 (25mg) for ages 1-3 years (50mg) for ages 4-8 years (100mg) for ages 9-12years | Combination Product: Magnesium and Vitamin B6<br>* Magnesium and Vitamin B6 will be given to the enrolled patients for 3 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autism Spectrum Disorder | General observation, Cognitive Working, socialization, Communication, Sensory Dysfunction. At first a autism will be diagnosed by DSM-5 .Then the above mention criterias along with the severity will be diagnosed by Autism Diagnostic Checklist tool by a psychologist. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autism Spectrum Disorder | The Autism Diagnostic Checklist will be repeated to compare the outcomes in terms of General observation, Cognitive Working, socialization, Communication, Sensory along with the severity of the Autism. | 0 month |