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Completed

NCT Number: NCT02508922

Trial of Vitamin D3 Supplementation in Paediatric Autism

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Children's Hopsital, Dublin, Ireland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Vitamin D3

Dietary Supplement

2,000iu vitamin D drops will be taken daily for 20 weeks

Other names: cholecalciferol

Placebo

Dietary Supplement

Matching placebo drops will be taken daily for 20 weeks

Primary outcomes

  1. Change from baseline in stereotypic behaviour from the aberrant behaviour checklist

    Time frame: Day 1 and day 140

    A subscale derived from the validated aberrant behaviour checklist

Secondary outcomes

  1. Change from baseline in serum 25-hydroxyvitamin D levels

    Time frame: Day 1 and day 140

    Total vitamin D levels

  2. Change from baseline in serum calcium levels, corrected for albumin

    Time frame: Day 1 and day 140

    Total serum calcium levels indicating calcium balance.

  3. Change from baseline in aberrant behaviour checklist

    Time frame: Day 1 and day 140

    A validated scale for use in autism

  4. Change from baseline in cytokines

    Time frame: Day 1 and day 140

    Serum will be analysed for specific cytokines

  5. Change from baseline in autoimmune markers

    Time frame: Day 1 and day 140

    Serum will be analysed for specific autoimmune markers

  6. Change from baseline in behaviour Assessment System for Children - Second Edition

    Time frame: Day 1 and day 140

    A validated scale for use in autism

  7. Change from baseline in repetitive behavior Scale - Revised

    Time frame: Day 1 and day 140

    A validated scale for use in autism

  8. Change from baseline in Social Responsiveness Scale

    Time frame: Day 1 and day 140

    A validated scale for use in autism

  9. Change from baseline in Developmental Disabilities-Children's Global Assessment Scale

    Time frame: Day 1 and day 140

    A clinical global impression of autism

  10. Change from baseline in Vitamin D and Sun Questionnaire

    Time frame: Day 1 and day 140

    A scale assessing behaviour related to vitamin D

Sponsors and collaborators

Lead sponsor

University of Dublin, Trinity College

Other

Collaborators

  • The National Children's Hospital, Tallaght

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 27, 2015
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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