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| Name | Class |
|---|---|
| The National Children's Hospital, Tallaght | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 | Experimental | 2000iu vitamin D will be taken daily for 20 weeks. |
|
| Placebo | Placebo Comparator | Matching placebo drops will be taken daily for 20 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement | 2,000iu vitamin D drops will be taken daily for 20 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in serum 25-hydroxyvitamin D levels | Total vitamin D levels | Day 1 and day 140 |
| Change from baseline in serum calcium levels, corrected for albumin | Total serum calcium levels indicating calcium balance. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Children's Hopsital | Dublin | Dublin | D24 | Ireland | ||
| Linn Dara and BeechPark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17920208 | Background | 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. | |
| 20219042 | Background | 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. |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Dietary Supplement | Matching placebo drops will be taken daily for 20 weeks |
|
| Day 1 and day 140 |
| Change from baseline in aberrant behaviour checklist | A validated scale for use in autism | Day 1 and day 140 |
| Change from baseline in cytokines | Serum will be analysed for specific cytokines | Day 1 and day 140 |
| Change from baseline in autoimmune markers | Serum will be analysed for specific autoimmune markers | Day 1 and day 140 |
| Change from baseline in behaviour Assessment System for Children - Second Edition | A validated scale for use in autism | Day 1 and day 140 |
| Change from baseline in repetitive behavior Scale - Revised | A validated scale for use in autism | Day 1 and day 140 |
| Change from baseline in Social Responsiveness Scale | A validated scale for use in autism | Day 1 and day 140 |
| Change from baseline in Developmental Disabilities-Children's Global Assessment Scale | A clinical global impression of autism | Day 1 and day 140 |
| Change from baseline in Vitamin D and Sun Questionnaire | A scale assessing behaviour related to vitamin D | Day 1 and day 140 |
| Dublin |
| D10 |
| Ireland |
| Trinity College Dublin | Dublin | D2 | Ireland |
| 21395563 | Background | 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. |
| 22522213 | Background | 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. |
| 22898564 | Background | 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. |
| 23725905 | Background | 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. |
| 24494055 | Background | 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. |
| 24558199 | Background | 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. |
| 25511123 | Background | 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. |
| 25876214 | Background | 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. |
| 28626020 | Derived | 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. |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |