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出境医 / 临床实验 / Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients

Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients

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.

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

Study Design
Layout table for study information
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
Arms and Interventions
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
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

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
Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 24, 2019
Last Update Posted Date July 31, 2019
Actual Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019) 		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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients
Official Title  ICMJE Vitamin B6 and Magnesium on Neurobehavioral Status of Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Autism Spectrum Disorder
Intervention  ICMJE Combination Product: Magnesium and Vitamin B6
Magnesium and Vitamin B6 will be given to the enrolled patients for 3 months
Study Arms  ICMJE
  • 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
    Intervention: Combination Product: Magnesium and Vitamin B6
  • 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
    Intervention: Combination Product: Magnesium and Vitamin B6
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 23, 2019) 		50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2019
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03963479
Other Study ID Numbers  ICMJE BSMMU/2018/14607
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Farhana Khan, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study Sponsor  ICMJE Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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