Trial of Vitamin D3 Supplementation in Paediatric Autism
NCT ID: NCT02508922
Last Updated: 2016-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2015-09-30
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Vitamin D3
2000iu vitamin D will be taken daily for 20 weeks.
Vitamin D3
2,000iu vitamin D drops will be taken daily for 20 weeks
Placebo
Matching placebo drops will be taken daily for 20 weeks
Placebo
Matching placebo drops will be taken daily for 20 weeks
Interventions
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Vitamin D3
2,000iu vitamin D drops will be taken daily for 20 weeks
Placebo
Matching placebo drops will be taken daily for 20 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable medication regimen
* Tolerate phlebotomy
Exclusion Criteria
* Epilepsy
* Renal/liver/gastrointestinal disease
3 Years
12 Years
ALL
No
Sponsors
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The National Children's Hospital, Tallaght
OTHER
University of Dublin, Trinity College
OTHER
Responsible Party
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Conor Kerley
Dietitian and Nutrition Scientist
Locations
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National Children's Hopsital
Dublin, Dublin, Ireland
Linn Dara and BeechPark
Dublin, , Ireland
Trinity College Dublin
Dublin, , Ireland
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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NCHVitDASD
Identifier Type: -
Identifier Source: org_study_id