Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients
Vitamin B6 and Magnesium on Neurobehavioral Status of Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Study
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 15, 2019
CompletedFirst Posted
Study publicly available on registry
May 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedJuly 31, 2019
May 1, 2019
7 months
May 15, 2019
July 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
3 months
Secondary Outcomes (1)
Autism Spectrum Disorder
0 month
Study Arms (2)
Magnesium-Vitamin B6
ACTIVE COMPARATORMagnesium (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
Placebo
PLACEBO COMPARATORMagnesium (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
Interventions
Magnesium and Vitamin B6 will be given to the enrolled patients for 3 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Farhana Khan
Dhaka, 02, Bangladesh
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident
Study Record Dates
First Submitted
May 15, 2019
First Posted
May 24, 2019
Study Start
January 1, 2019
Primary Completion
July 31, 2019
Study Completion
July 31, 2019
Last Updated
July 31, 2019
Record last verified: 2019-05