Trial of Vitamin D3 Supplementation in Paediatric Autism

Study Overview
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Brief Summary
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To build on a recent case study and open label trial, the investigators want to find out if vitamin D supplementation can influence behavioural and core symptoms of autism.

Detailed Description
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The investigators will assess behavioural and core symptoms of autism before and after 20 weeks of vitamin D supplementation in a double-blind, placebo-controlled trial.

Official Title
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Vitamin D3 for Autism Spectrum Disorder: a Randomized, Double-blind, Placebo-controlled Trial.

Conditions
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Autism

Intervention / Treatment
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* Dietary Supplement: Vitamin D3
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive autism diagnostic observation schedule Stable medication regimen Tolerate phlebotomy Exclusion Criteria: Unstable or very severe autism Epilepsy Renal/liver/gastrointestinal disease

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3<br>2000iu vitamin D will be taken daily for 20 weeks. | Dietary Supplement: Vitamin D3<br>* 2,000iu vitamin D drops will be taken daily for 20 weeks<br>* Other names: cholecalciferol;|
| Placebo Comparator: Placebo<br>Matching placebo drops will be taken daily for 20 weeks | Dietary Supplement: Placebo<br>* Matching placebo drops will be taken daily for 20 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in stereotypic behaviour from the aberrant behaviour checklist | A subscale derived from the validated aberrant behaviour checklist | Day 1 and day 140 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in serum 25-hydroxyvitamin D levels | Total vitamin D levels | Day 1 and day 140 | 
| Change from baseline in serum calcium levels, corrected for albumin | Total serum calcium levels indicating calcium balance. | Day 1 and day 140 | 
| Change from baseline in aberrant behaviour checklist | A validated scale for use in autism | Day 1 and day 140 | 
| Change from baseline in cytokines | Serum will be analysed for specific cytokines | Day 1 and day 140 | 
| Change from baseline in autoimmune markers | Serum will be analysed for specific autoimmune markers | Day 1 and day 140 | 
| Change from baseline in behaviour Assessment System for Children - Second Edition | A validated scale for use in autism | Day 1 and day 140 | 
| Change from baseline in repetitive behavior Scale - Revised | A validated scale for use in autism | Day 1 and day 140 | 
| Change from baseline in Social Responsiveness Scale | A validated scale for use in autism | Day 1 and day 140 | 
| Change from baseline in Developmental Disabilities-Children's Global Assessment Scale | A clinical global impression of autism | Day 1 and day 140 | 
| Change from baseline in Vitamin D and Sun Questionnaire | A scale assessing behaviour related to vitamin D | Day 1 and day 140 |