Trial of Vitamin D3 Supplementation in Paediatric Autism

October 24, 2016 updated by: Conor Kerley, University of Dublin, Trinity College

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, D10
        • Linn Dara and BeechPark
      • Dublin, Ireland, D24
        • National Children's Hopsital
      • Dublin, Ireland, D2
        • Trinity College Dublin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D3
2000iu vitamin D will be taken daily for 20 weeks.
Dietary supplement: Vitamin D3
2,000iu vitamin D drops will be taken daily for 20 weeks
Other Names:
  • cholecalciferol
Placebo Comparator: Placebo
Matching placebo drops will be taken daily for 20 weeks
Dietary supplement: Placebo
Matching placebo drops will be taken daily for 20 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1 and day 140

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dublin, Trinity College

Collaborators

The National Children's Hospital, Tallaght

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

July 24, 2015

First Submitted That Met QC Criteria

July 24, 2015

First Posted (Estimate)

July 27, 2015

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCHVitDASD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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