Clinical trial NCT02508922: Trial of Vitamin D3 Supplementation in Paediatric Autism
Official title: Vitamin D3 for Autism Spectrum Disorder: a Randomized, Double-blind, Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: The National Children's Hospital, Tallaght
First posted: 2015-07-27
Enrollment: 42
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Change from baseline in stereotypic behaviour from the aberrant behaviour checklist
timeFrame: Day 1 and day 140
Secondary outcomes:
measure: Change from baseline in serum 25-hydroxyvitamin D levels
timeFrame: Day 1 and day 140
measure: Change from baseline in serum calcium levels, corrected for albumin
timeFrame: Day 1 and day 140
measure: Change from baseline in aberrant behaviour checklist
timeFrame: Day 1 and day 140
measure: Change from baseline in cytokines
timeFrame: Day 1 and day 140
measure: Change from baseline in autoimmune markers
timeFrame: Day 1 and day 140
measure: Change from baseline in behaviour Assessment System for Children - Second Edition
timeFrame: Day 1 and day 140
measure: Change from baseline in repetitive behavior Scale - Revised
timeFrame: Day 1 and day 140
measure: Change from baseline in Social Responsiveness Scale
timeFrame: Day 1 and day 140
measure: Change from baseline in Developmental Disabilities-Children's Global Assessment Scale
timeFrame: Day 1 and day 140
measure: Change from baseline in Vitamin D and Sun Questionnaire
timeFrame: Day 1 and day 140
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Linn Dara and BeechPark
city: Dublin
country: Ireland
facility: National Children's Hopsital
city: Dublin
country: Ireland
facility: Trinity College Dublin
Study officials:
References:
citation: 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.
citation: Eyles 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.
citation: Becker 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.
citation: Kocovska 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.
citation: Mostafa 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.
citation: Cannell 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.
citation: Cannell 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.
citation: Patrick 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.
citation: Jia 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.
citation: Saad 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.
citation: Kerley 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.