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Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03963479
Recruitment Status : Unknown
Verified May 2019 by Dr. Farhana Khan, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
Recruitment status was:  Recruiting
First Posted : May 24, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Farhana Khan, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study Description
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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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Combination Product: Magnesium and Vitamin B6 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Vitamin B6 and Magnesium on Neurobehavioral Status of Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Study
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
 Combination Product: Magnesium and Vitamin B6
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
 Combination Product: Magnesium and Vitamin B6
Magnesium and Vitamin B6 will be given to the enrolled patients for 3 months


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963479


Contacts
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Contact: Farhana Khan, MBBS 8801674255083 farhanakhan488@gmail.com
Contact: Md Sayedur Rahman, MBBS, MPhil 8801971840757 srkhasru@gmail.com

Locations
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Bangladesh
Farhana Khan Recruiting
Dhaka, Bangladesh, 02
Contact: Md. Sayedur Rahman, MBBS, MPhil    8801971840757    srkhasru@gmail.com   
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
More Information
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Responsible Party: Dr. Farhana Khan, Resident, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT03963479    
Other Study ID Numbers: BSMMU/2018/14607
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Vitamin B 6
Pyridoxal
 Pyridoxine
Vitamins
Micronutrients
Physiological Effects of Drugs
Vitamin B Complex