Back to resultsA Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children
Primary Purpose
Autism
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Autism
Eligibility Criteria
Inclusion Criteria:
- Patients fulfill fourth edition of Diagnostic and statistical manual of mental Disorders (DSM 4th) criteria for autism
Exclusion Criteria:
- Patients who had seizures within the past year or History of kidney or liver disease or Taking the following medications or supplements that may affect vitamin D level (as antiepileptic, corticosteroids or immunosuppressant) were excluded from the study. None of the study participants received vitamin D or calcium therapy in the past 6 months and there were no change in children's treatment regimen (including medications) within 1 month prior to the study.
Sites / Locations
- Faculty of Pharmacy AinShams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Vitamin D group
Placebo group
Arm Description
Patients will receive vitamin D drug with generic name: V drops manufactured by Medical Union Pharmaceuticals, Egypt Dosage form: liquid drops Dosage, frequency, and Duration:1000 international units per day for 3 months then 1000 international units per 25 pounds per day for another 3 months.
Patients will receive glucose syrup same taste and color as vitamin D3 drops with same dosage regimen to vitamin D group.
Outcomes
Primary Outcome Measures
Effect of vitamin D on changes in behavioral measures (Childhood autism rating scale)
Effect of vitamin D on changes in behavioral measures (autism treatment evaluation checklist)
Secondary Outcome Measures
Effect of vitamin D on calcium level
Effect of vitamin D on phosphorous level
Effect of vitamin D on alkaline phosphatase level
Effect of vitamin D on parathyroid hormone level
Effect of vitamin D on liver function test (alanine transaminase and aspartate transaminase)
Effect of vitamin D on kidney function test (Blood urea nitrogen and serum creatinine)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02550912
Brief Title
A Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children
Official Title
A Pilot Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study to determine whether high dose vitamin D has positive effect on behavior of autistic children.
Detailed Description
Double blinded placebo controlled study to determine effect of two different doses of vitamin D on Behavioral domains in autistic children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D group
Arm Type
Active Comparator
Arm Description
Patients will receive vitamin D drug with generic name: V drops manufactured by Medical Union Pharmaceuticals, Egypt Dosage form: liquid drops Dosage, frequency, and Duration:1000 international units per day for 3 months then 1000 international units per 25 pounds per day for another 3 months.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Patients will receive glucose syrup same taste and color as vitamin D3 drops with same dosage regimen to vitamin D group.
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
vitamin D drops
Intervention Description
vitamin D drops for paediatrics
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
glucose syrup
Intervention Description
glucose syrup with same taste and color to vitamin D3 drops
Primary Outcome Measure Information:
Title
Effect of vitamin D on changes in behavioral measures (Childhood autism rating scale)
Time Frame
At baseline, 12 weeks ,24 weeks
Title
Effect of vitamin D on changes in behavioral measures (autism treatment evaluation checklist)
Time Frame
At baseline, 12 weeks ,24 weeks
Secondary Outcome Measure Information:
Title
Effect of vitamin D on calcium level
Time Frame
At baseline, 12 weeks ,24 weeks
Title
Effect of vitamin D on phosphorous level
Time Frame
At baseline, 12 weeks ,24 weeks
Title
Effect of vitamin D on alkaline phosphatase level
Time Frame
At baseline,12 weeks ,24 weeks
Title
Effect of vitamin D on parathyroid hormone level
Time Frame
At baseline,12 weeks ,24 weeks
Title
Effect of vitamin D on liver function test (alanine transaminase and aspartate transaminase)
Time Frame
At baseline, 12 weeks ,24 weeks
Title
Effect of vitamin D on kidney function test (Blood urea nitrogen and serum creatinine)
Time Frame
At baseline, 12 weeks ,24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients fulfill fourth edition of Diagnostic and statistical manual of mental Disorders (DSM 4th) criteria for autism
Exclusion Criteria:
Patients who had seizures within the past year or History of kidney or liver disease or Taking the following medications or supplements that may affect vitamin D level (as antiepileptic, corticosteroids or immunosuppressant) were excluded from the study. None of the study participants received vitamin D or calcium therapy in the past 6 months and there were no change in children's treatment regimen (including medications) within 1 month prior to the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sarah f mohamed fahmy, masters
Organizational Affiliation
assistant lecturer clinical pharmacy ainshams university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
nagwa A sabri, professor
Organizational Affiliation
professor in clinical pharmacy Ainshams university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
manal H elhamamsy, professor
Organizational Affiliation
professor in clinical pharmacy Ainshams university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
mohamed A elsawi, professor
Organizational Affiliation
professor in pediatrics and genetics ainshams university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
osama k zaki, consultant
Organizational Affiliation
medical consultant in paediatrics and genetics unit ainshams university
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Pharmacy AinShams University
City
Cairo
ZIP/Postal Code
02
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children
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