Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients

NCT ID: NCT03963479

Last Updated: 2019-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-07-31

Brief Summary

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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

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Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Magnesium-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

Group Type ACTIVE_COMPARATOR

Magnesium and Vitamin B6

Intervention Type COMBINATION_PRODUCT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Magnesium and Vitamin B6

Intervention Type COMBINATION_PRODUCT

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

Interventions

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Magnesium and Vitamin B6

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role lead

Responsible Party

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Dr. Farhana Khan

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Farhana Khan

Dhaka, , Bangladesh

Site Status RECRUITING

Countries

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Bangladesh

Central Contacts

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Farhana Khan, MBBS

Role: CONTACT

Phone: 8801674255083

Email: [email protected]

Md Sayedur Rahman, MBBS, MPhil

Role: CONTACT

Phone: 8801971840757

Email: [email protected]

Facility Contacts

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Md. Sayedur Rahman, MBBS, MPhil

Role: primary

Other Identifiers

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BSMMU/2018/14607

Identifier Type: -

Identifier Source: org_study_id