A Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children

Study Overview
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Brief Summary
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The purpose of this study to determine whether high dose vitamin D has positive effect on behavior of autistic children.

Detailed Description
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Double blinded placebo controlled study to determine effect of two different doses of vitamin D on Behavioral domains in autistic children.

Official Title
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A Pilot Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children

Conditions
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Autism

Intervention / Treatment
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* Drug: Vitamin D3
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D group<br>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. | Drug: Vitamin D3<br>* vitamin D drops for paediatrics<br>* Other names: vitamin D drops;|
| Placebo Comparator: Placebo group<br>Patients will receive glucose syrup same taste and color as vitamin D3 drops with same dosage regimen to vitamin D group. | Other: Placebo<br>* glucose syrup with same taste and color to vitamin D3 drops<br>* Other names: glucose syrup;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of vitamin D on changes in behavioral measures (Childhood autism rating scale) |  | At baseline, 12 weeks ,24 weeks | 
| Effect of vitamin D on changes in behavioral measures (autism treatment evaluation checklist) |  | At baseline, 12 weeks ,24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of vitamin D on calcium level |  | At baseline, 12 weeks ,24 weeks | 
| Effect of vitamin D on phosphorous level |  | At baseline, 12 weeks ,24 weeks | 
| Effect of vitamin D on alkaline phosphatase level |  | At baseline,12 weeks ,24 weeks | 
| Effect of vitamin D on parathyroid hormone level |  | At baseline,12 weeks ,24 weeks | 
| Effect of vitamin D on liver function test (alanine transaminase and aspartate transaminase) |  | At baseline, 12 weeks ,24 weeks | 
| Effect of vitamin D on kidney function test (Blood urea nitrogen and serum creatinine) |  | At baseline, 12 weeks ,24 weeks |