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Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients

Primary Purpose

Autism Spectrum Disorder

Status

Unknown status

Phase

Phase 2

Locations

Bangladesh

Study Type

Interventional

Intervention

Magnesium and Vitamin B6

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Farhana KhanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Magnesium-Vitamin B6

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03963479

First Posted

May 15, 2019

Last Updated

July 30, 2019

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

1. Study Identification

Unique Protocol Identification Number

NCT03963479

Brief Title

Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

July 31, 2019 (Anticipated)

Study Completion Date

July 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Magnesium-Vitamin B6

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Combination Product

Intervention Name(s)

Magnesium and Vitamin B6

Intervention Description

Magnesium and Vitamin B6 will be given to the enrolled patients for 3 months

Primary Outcome Measure Information:

Title

Autism Spectrum Disorder

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Autism Spectrum Disorder

Description

Time Frame

0 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Farhana Khan, MBBS

Phone

8801674255083

farhanakhan488@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Md Sayedur Rahman, MBBS, MPhil

Phone

8801971840757

srkhasru@gmail.com

Facility Information:

Facility Name

Farhana Khan

City

Dhaka

ZIP/Postal Code

Country

Bangladesh

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Md. Sayedur Rahman, MBBS, MPhil

Phone

8801971840757

srkhasru@gmail.com

12. IPD Sharing Statement

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Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients

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