Trial of Vitamin D3 Supplementation in Paediatric Autism
Vitamin D3 for Autism Spectrum Disorder: a Randomized, Double-blind, Placebo-controlled Trial.
1 other identifier
interventional
42
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2015
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2015
CompletedFirst Posted
Study publicly available on registry
July 27, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedOctober 25, 2016
October 1, 2016
9 months
July 24, 2015
October 24, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in stereotypic behaviour from the aberrant behaviour checklist
A subscale derived from the validated aberrant behaviour checklist
Day 1 and day 140
Secondary Outcomes (10)
Change from baseline in serum 25-hydroxyvitamin D levels
Day 1 and day 140
Change from baseline in serum calcium levels, corrected for albumin
Day 1 and day 140
Change from baseline in aberrant behaviour checklist
Day 1 and day 140
Change from baseline in cytokines
Day 1 and day 140
Change from baseline in autoimmune markers
Day 1 and day 140
- +5 more secondary outcomes
Study Arms (2)
Vitamin D3
EXPERIMENTAL2000iu vitamin D will be taken daily for 20 weeks.
Placebo
PLACEBO COMPARATORMatching placebo drops will be taken daily for 20 weeks
Interventions
2,000iu vitamin D drops will be taken daily for 20 weeks
Eligibility Criteria
You may qualify if:
- Positive autism diagnostic observation schedule
- Stable medication regimen
- Tolerate phlebotomy
You may not qualify if:
- Unstable or very severe autism
- Epilepsy
- Renal/liver/gastrointestinal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
National Children's Hopsital
Dublin, Dublin, D24, Ireland
Linn Dara and BeechPark
Dublin, D10, Ireland
Trinity College Dublin
Dublin, D2, Ireland
Related Publications (11)
Cannell JJ. Autism and vitamin D. Med Hypotheses. 2008;70(4):750-9. doi: 10.1016/j.mehy.2007.08.016. Epub 2007 Oct 24.
PMID: 17920208BACKGROUNDEyles DW. Vitamin D and autism: does skin colour modify risk? Acta Paediatr. 2010 May;99(5):645-647. doi: 10.1111/j.1651-2227.2010.01797.x. Epub 2010 Mar 8. No abstract available.
PMID: 20219042BACKGROUNDBecker KG. Autism, immune dysfunction and Vitamin D. Acta Psychiatr Scand. 2011 Jul;124(1):74; author reply 74-5. doi: 10.1111/j.1600-0447.2011.01688.x. Epub 2011 Mar 13. No abstract available.
PMID: 21395563BACKGROUNDKocovska E, Fernell E, Billstedt E, Minnis H, Gillberg C. Vitamin D and autism: clinical review. Res Dev Disabil. 2012 Sep-Oct;33(5):1541-50. doi: 10.1016/j.ridd.2012.02.015. Epub 2012 Apr 21.
PMID: 22522213BACKGROUNDMostafa GA, Al-Ayadhi LY. Reduced serum concentrations of 25-hydroxy vitamin D in children with autism: relation to autoimmunity. J Neuroinflammation. 2012 Aug 17;9:201. doi: 10.1186/1742-2094-9-201.
PMID: 22898564BACKGROUNDCannell JJ. Autism, will vitamin D treat core symptoms? Med Hypotheses. 2013 Aug;81(2):195-8. doi: 10.1016/j.mehy.2013.05.004. Epub 2013 May 29.
PMID: 23725905BACKGROUNDCannell JJ, Grant WB. What is the role of vitamin D in autism? Dermatoendocrinol. 2013 Jan 1;5(1):199-204. doi: 10.4161/derm.24356.
PMID: 24494055BACKGROUNDPatrick RP, Ames BN. Vitamin D hormone regulates serotonin synthesis. Part 1: relevance for autism. FASEB J. 2014 Jun;28(6):2398-413. doi: 10.1096/fj.13-246546. Epub 2014 Feb 20.
PMID: 24558199BACKGROUNDJia F, Wang B, Shan L, Xu Z, Staal WG, Du L. Core symptoms of autism improved after vitamin D supplementation. Pediatrics. 2015 Jan;135(1):e196-8. doi: 10.1542/peds.2014-2121. Epub 2014 Dec 15.
PMID: 25511123BACKGROUNDSaad K, Abdel-Rahman AA, Elserogy YM, Al-Atram AA, Cannell JJ, Bjorklund G, Abdel-Reheim MK, Othman HA, El-Houfey AA, Abd El-Aziz NH, Abd El-Baseer KA, Ahmed AE, Ali AM. Vitamin D status in autism spectrum disorders and the efficacy of vitamin D supplementation in autistic children. Nutr Neurosci. 2016 Oct;19(8):346-351. doi: 10.1179/1476830515Y.0000000019. Epub 2015 Apr 15.
PMID: 25876214BACKGROUNDKerley CP, Power C, Gallagher L, Coghlan D. Lack of effect of vitamin D3 supplementation in autism: a 20-week, placebo-controlled RCT. Arch Dis Child. 2017 Nov;102(11):1030-1036. doi: 10.1136/archdischild-2017-312783. Epub 2017 Jun 16.
PMID: 28626020DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dietitian and Nutrition Scientist
Study Record Dates
First Submitted
July 24, 2015
First Posted
July 27, 2015
Study Start
September 1, 2015
Primary Completion
June 1, 2016
Study Completion
July 1, 2016
Last Updated
October 25, 2016
Record last verified: 2016-10