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Trial of Vitamin D3 Supplementation in Paediatric Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02508922
Recruitment Status : Completed
First Posted : July 27, 2015
Last Update Posted : October 25, 2016
Sponsor:
Collaborator:
The National Children's Hospital, Tallaght
Information provided by (Responsible Party):
Conor Kerley, 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.

Condition or disease Intervention/treatment Phase
Autism Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Vitamin D3 for Autism Spectrum Disorder: a Randomized, Double-blind, Placebo-controlled Trial.
Study Start Date : September 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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 Name: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02508922


Locations
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Ireland
Linn Dara and BeechPark
Dublin, Ireland, D10
National Children's Hopsital
Dublin, Ireland, D24
Trinity College Dublin
Dublin, Ireland, D2
Sponsors and Collaborators
University of Dublin, Trinity College
The National Children's Hospital, Tallaght
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Conor Kerley, Dietitian and Nutrition Scientist, University of Dublin, Trinity College
ClinicalTrials.gov Identifier: NCT02508922    
Other Study ID Numbers: NCHVitDASD
First Posted: July 27, 2015    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents