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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Autism | Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo | Not Applicable |
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 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 3 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Positive autism diagnostic observation schedule
- Stable medication regimen
- Tolerate phlebotomy
Exclusion Criteria:
- Unstable or very severe autism
- Epilepsy
- Renal/liver/gastrointestinal disease

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
Ireland | |
Linn Dara and BeechPark | |
Dublin, Ireland, D10 | |
National Children's Hopsital | |
Dublin, Ireland, D24 | |
Trinity College Dublin | |
Dublin, Ireland, D2 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders Vitamin D |
Cholecalciferol Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |