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Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients

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ClinicalTrials.gov Identifier: NCT03963479
Recruitment Status : Recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Farhana Khan, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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

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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


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




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.



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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

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: Abdul Basit Ibne Momen, MBBS, MRCP 8801674255082 abdulbasit17@gmail.com

Locations
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Bangladesh
Farhana Khan Recruiting
Dhaka, Bangladesh, 02
Contact: Monira Parveen, MBBS    8801720010564    konica43@gmail.com   
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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Responsible Party: Dr. Farhana Khan, Resident, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT03963479     History of Changes
Other Study ID Numbers: BSMMU/2018/14607
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 24, 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
Vitamins
Vitamin B 6
Pyridoxal
Pyridoxine
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs