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Trial of Vitamin D3 Supplementation in Paediatric Autism

Primary Purpose

Autism

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
University of Dublin, Trinity College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Positive autism diagnostic observation schedule
  • Stable medication regimen
  • Tolerate phlebotomy

Exclusion Criteria:

  • Unstable or very severe autism
  • Epilepsy
  • Renal/liver/gastrointestinal disease

Sites / Locations

  • Linn Dara and BeechPark
  • National Children's Hopsital
  • Trinity College Dublin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D3

Placebo

Arm Description

2000iu vitamin D will be taken daily for 20 weeks.

Matching placebo drops will be taken daily for 20 weeks

Outcomes

Primary Outcome Measures

Change from baseline in stereotypic behaviour from the aberrant behaviour checklist
A subscale derived from the validated aberrant behaviour checklist

Secondary Outcome Measures

Change from baseline in serum 25-hydroxyvitamin D levels
Total vitamin D levels
Change from baseline in serum calcium levels, corrected for albumin
Total serum calcium levels indicating calcium balance.
Change from baseline in aberrant behaviour checklist
A validated scale for use in autism
Change from baseline in cytokines
Serum will be analysed for specific cytokines
Change from baseline in autoimmune markers
Serum will be analysed for specific autoimmune markers
Change from baseline in behaviour Assessment System for Children - Second Edition
A validated scale for use in autism
Change from baseline in repetitive behavior Scale - Revised
A validated scale for use in autism
Change from baseline in Social Responsiveness Scale
A validated scale for use in autism
Change from baseline in Developmental Disabilities-Children's Global Assessment Scale
A clinical global impression of autism
Change from baseline in Vitamin D and Sun Questionnaire
A scale assessing behaviour related to vitamin D

Full Information

First Posted
July 24, 2015
Last Updated
October 24, 2016
Sponsor
University of Dublin, Trinity College
Collaborators
The National Children's Hospital, Tallaght
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1. Study Identification

Unique Protocol Identification Number
NCT02508922
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Dublin, Trinity College
Collaborators
The National Children's Hospital, Tallaght

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3
Arm Type
Experimental
Arm Description
2000iu vitamin D will be taken daily for 20 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo drops will be taken daily for 20 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
cholecalciferol
Intervention Description
2,000iu vitamin D drops will be taken daily for 20 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Matching placebo drops will be taken daily for 20 weeks
Primary Outcome Measure Information:
Title
Change from baseline in stereotypic behaviour from the aberrant behaviour checklist
Description
A subscale derived from the validated aberrant behaviour checklist
Time Frame
Day 1 and day 140
Secondary Outcome Measure Information:
Title
Change from baseline in serum 25-hydroxyvitamin D levels
Description
Total vitamin D levels
Time Frame
Day 1 and day 140
Title
Change from baseline in serum calcium levels, corrected for albumin
Description
Total serum calcium levels indicating calcium balance.
Time Frame
Day 1 and day 140
Title
Change from baseline in aberrant behaviour checklist
Description
A validated scale for use in autism
Time Frame
Day 1 and day 140
Title
Change from baseline in cytokines
Description
Serum will be analysed for specific cytokines
Time Frame
Day 1 and day 140
Title
Change from baseline in autoimmune markers
Description
Serum will be analysed for specific autoimmune markers
Time Frame
Day 1 and day 140
Title
Change from baseline in behaviour Assessment System for Children - Second Edition
Description
A validated scale for use in autism
Time Frame
Day 1 and day 140
Title
Change from baseline in repetitive behavior Scale - Revised
Description
A validated scale for use in autism
Time Frame
Day 1 and day 140
Title
Change from baseline in Social Responsiveness Scale
Description
A validated scale for use in autism
Time Frame
Day 1 and day 140
Title
Change from baseline in Developmental Disabilities-Children's Global Assessment Scale
Description
A clinical global impression of autism
Time Frame
Day 1 and day 140
Title
Change from baseline in Vitamin D and Sun Questionnaire
Description
A scale assessing behaviour related to vitamin D
Time Frame
Day 1 and day 140

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Linn Dara and BeechPark
City
Dublin
ZIP/Postal Code
D10
Country
Ireland
Facility Name
National Children's Hopsital
City
Dublin
ZIP/Postal Code
D24
Country
Ireland
Facility Name
Trinity College Dublin
City
Dublin
ZIP/Postal Code
D2
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
17920208
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.
Results Reference
background
PubMed Identifier
20219042
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.
Results Reference
background
PubMed Identifier
21395563
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.
Results Reference
background
PubMed Identifier
22522213
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.
Results Reference
background
PubMed Identifier
22898564
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.
Results Reference
background
PubMed Identifier
23725905
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.
Results Reference
background
PubMed Identifier
24494055
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.
Results Reference
background
PubMed Identifier
24558199
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.
Results Reference
background
PubMed Identifier
25511123
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.
Results Reference
background
PubMed Identifier
25876214
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.
Results Reference
background
PubMed Identifier
28626020
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.
Results Reference
derived

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Trial of Vitamin D3 Supplementation in Paediatric Autism

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