- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03963479
Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients
July 30, 2019 updated by: Dr. Farhana Khan, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Vitamin B6 and Magnesium on Neurobehavioral Status of Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Farhana Khan, MBBS
- Phone Number: 8801674255083
- Email: farhanakhan488@gmail.com
Study Contact Backup
- Name: Md Sayedur Rahman, MBBS, MPhil
- Phone Number: 8801971840757
- Email: srkhasru@gmail.com
Study Locations
-
-
-
Dhaka, Bangladesh, 02
- Recruiting
- Farhana Khan
-
Contact:
- Md. Sayedur Rahman, MBBS, MPhil
- Phone Number: 8801971840757
- Email: srkhasru@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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 will be given to the enrolled patients for 3 months
|
Placebo Comparator: 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 will be given to the enrolled patients for 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Autism Spectrum Disorder
Time Frame: 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. |
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Autism Spectrum Disorder
Time Frame: 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.
|
0 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Anticipated)
July 31, 2019
Study Completion (Anticipated)
July 31, 2019
Study Registration Dates
First Submitted
May 15, 2019
First Submitted That Met QC Criteria
May 23, 2019
First Posted (Actual)
May 24, 2019
Study Record Updates
Last Update Posted (Actual)
July 31, 2019
Last Update Submitted That Met QC Criteria
July 30, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BSMMU/2018/14607
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autism Spectrum Disorder
-
Stanford UniversityCalifornia Department of Developmental ServicesRecruitingAutism Spectrum Disorder | Autistic Disorder | Autism | Autism Spectrum Disorders | Autistic Disorders Spectrum | Autistic Spectrum Disorder | Autistic Spectrum DisordersUnited States
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-
Florida Gulf Coast UniversityCompletedAutism Spectrum Disorder High-FunctioningUnited States
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Hospital Universitario Dr. Jose E. GonzalezUnknownAutism | Autism SpectrumMexico
-
National Taiwan University HospitalCompletedAutism Spectrum Disorder High-FunctioningTaiwan
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