Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients
NCT ID: NCT03963479
Last Updated: 2019-07-31
Study Results
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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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2019-01-01
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
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
Magnesium and Vitamin B6
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
Magnesium and Vitamin B6
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
Eligibility Criteria
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Inclusion Criteria
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
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
2 Years
12 Years
ALL
No
Sponsors
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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
OTHER
Responsible Party
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Dr. Farhana Khan
Resident
Locations
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Farhana Khan
Dhaka, , Bangladesh
Countries
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Central Contacts
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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