Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients

Phase 2

• Conditions: Autism Spectrum Disorder
• Interventions: Combination Product: Magnesium and Vitamin B6

• Registration Number: NCT03963479
• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2019-05
• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-23
• Study First Posted: 2019-05-24
• Last Update Submitted: 2019-07-30
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Children between 2 to 12 years of age suspected ASD assessed by DSM-5 and ADCL tool
2. Each patient will be free of psychoactive medication for atleast 3 months prior to the entry into the trial
3. Newly diagnosed patient
4. Co-morbid neurological disorder like hyperactivity

Exclusion Criteria

1. Patients with chronic diseases or any known metabolic or hormonal diseases
2. Patients with any known chromosomal or genetic syndromes
3. Patients unable to give informed consent
4. Patients unable to travel to clinical visits or non co-operative

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Magnesium and Vitamin B6	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
Magnesium-Vitamin B6	Magnesium and Vitamin B6	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

Primary Outcome Measures

Name	Time	Method
Autism Spectrum Disorder	3 months	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

Name	Time	Method
Autism Spectrum Disorder	0 month	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.

Trial Locations

Locations (1)

Farhana Khan; 🇧🇩 Dhaka, Bangladesh