Trial of Vitamin D3 Supplementation in Paediatric Autism

Not Applicable

Completed

• Conditions: Autism
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Vitamin D3

• Registration Number: NCT02508922
• Lead Sponsor: University of Dublin, Trinity College

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-07-24
• Study First Submitted QC: 2015-07-24
• Study First Posted: 2015-07-27
• Study Start: 2015-09
• Primary Completion: 2016-06
• Study Completion: 2016-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Positive autism diagnostic observation schedule
• Stable medication regimen
• Tolerate phlebotomy

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Exclusion Criteria

• Unstable or very severe autism
• Epilepsy
• Renal/liver/gastrointestinal disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo drops will be taken daily for 20 weeks
Vitamin D3	Vitamin D3	2000iu vitamin D will be taken daily for 20 weeks.

Primary Outcome Measures

Name	Time	Method
Change from baseline in stereotypic behaviour from the aberrant behaviour checklist	Day 1 and day 140	A subscale derived from the validated aberrant behaviour checklist

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Linn Dara and BeechPark; 🇮🇪 Dublin, Ireland

National Children's Hopsital; 🇮🇪 Dublin, Ireland

Trinity College Dublin; 🇮🇪 Dublin, Ireland