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
Sponsored by
About this trial
This is an interventional supportive care trial for Autism Spectrum Disorder
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
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
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
No
Studies a U.S. FDA-regulated Device Product
No
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
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Autism Spectrum Disorder
Description
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.
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
No
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
Email
farhanakhan488@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Md Sayedur Rahman, MBBS, MPhil
Phone
8801971840757
Email
srkhasru@gmail.com
Facility Information:
Facility Name
Farhana Khan
City
Dhaka
ZIP/Postal Code
02
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Md. Sayedur Rahman, MBBS, MPhil
Phone
8801971840757
Email
srkhasru@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients
We'll reach out to this number within 24 hrs