Trial of Vitamin D3 Supplementation in Paediatric Autism

Autism Clinical Trial

Official title:

Vitamin D3 for Autism Spectrum Disorder: a Randomized, Double-blind, Placebo-controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02508922
• Other study ID #: NCHVitDASD
• Status: Completed
• Phase: N/A
• First received: July 24, 2015
• Last updated: October 24, 2016
• Start date: September 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: University of Dublin, Trinity College
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

Inclusion Criteria:

• Positive autism diagnostic observation schedule

• Stable medication regimen

• Tolerate phlebotomy

Exclusion Criteria:

• Unstable or very severe autism

• Epilepsy

• Renal/liver/gastrointestinal disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Ireland	Linn Dara and BeechPark	Dublin
Ireland	National Children's Hopsital	Dublin
Ireland	Trinity College Dublin	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
University of Dublin, Trinity College	The National Children's Hospital, Tallaght

Country where clinical trial is conducted

Ireland, 

References & Publications (10)

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. — View 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. — View Citation

Cannell JJ. Autism and vitamin D. Med Hypotheses. 2008;70(4):750-9. Epub 2007 Oct 24. — View 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. — View Citation

Eyles DW. Vitamin D and autism: does skin colour modify risk? Acta Paediatr. 2010 May;99(5):645-7. doi: 10.1111/j.1651-2227.2010.01797.x. Epub 2010 Mar 8. — View 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. — View Citation

Kocovská 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. — View 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. — View 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. Review. — View Citation

Saad K, Abdel-Rahman AA, Elserogy YM, Al-Atram AA, Cannell JJ, Bjørklund 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from baseline in serum 25-hydroxyvitamin D levels	Total vitamin D levels	Day 1 and day 140	Yes
Secondary	Change from baseline in serum calcium levels, corrected for albumin	Total serum calcium levels indicating calcium balance.	Day 1 and day 140	Yes
Secondary	Change from baseline in aberrant behaviour checklist	A validated scale for use in autism	Day 1 and day 140	No
Secondary	Change from baseline in cytokines	Serum will be analysed for specific cytokines	Day 1 and day 140	No
Secondary	Change from baseline in autoimmune markers	Serum will be analysed for specific autoimmune markers	Day 1 and day 140	No
Secondary	Change from baseline in behaviour Assessment System for Children - Second Edition	A validated scale for use in autism	Day 1 and day 140	No
Secondary	Change from baseline in repetitive behavior Scale - Revised	A validated scale for use in autism	Day 1 and day 140	No
Secondary	Change from baseline in Social Responsiveness Scale	A validated scale for use in autism	Day 1 and day 140	No
Secondary	Change from baseline in Developmental Disabilities—Children's Global Assessment Scale	A clinical global impression of autism	Day 1 and day 140	Yes
Secondary	Change from baseline in Vitamin D and Sun Questionnaire	A scale assessing behaviour related to vitamin D	Day 1 and day 140	No