AutismNCT02508922
Trial of Vitamin D3 Supplementation in Paediatric Autism
A study testing Vitamin D3 in people with Autism, run by University of Dublin, Trinity College at 3 sites in Ireland.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Autism
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 3 sitesIreland
- Study dates
- Sep 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Positive autism diagnostic observation schedule
- Stable medication regimen
- Tolerate phlebotomy
Who cannot join
- Unstable or very severe autism
- Epilepsy
- Renal/liver/gastrointestinal disease
Trial locations and contacts
3 sites in 1 country.
Ireland3 sites
National Children's Hopsital
Dublin, Dublin, D24
Linn Dara and BeechPark
Dublin, D10
Trinity College Dublin
Dublin, D2
About this study
Official title: Vitamin D3 for Autism Spectrum Disorder: a Randomized, Double-blind, Placebo-controlled Trial.
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.
Read the 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.
- Conditions
- Autism
- Being tested
- Vitamin D3, Placebo
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called cholecalciferol
2,000iu vitamin D drops will be taken daily for 20 weeks
PlaceboDietary supplement
Matching placebo drops will be taken daily for 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Experimental | 2000iu vitamin D will be taken daily for 20 weeks. Receives: Dietary Supplement: Vitamin D3 |
| Placebo | Placebo comparator | Matching placebo drops will be taken daily for 20 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in stereotypic behaviour from the aberrant behaviour checklist
A subscale derived from the validated aberrant behaviour checklist
Measured: Day 1 and day 140
Secondary outcomes (10)
Change from baseline in serum 25-hydroxyvitamin D levels
Total vitamin D levels
Measured: Day 1 and day 140
Change from baseline in serum calcium levels, corrected for albumin
Total serum calcium levels indicating calcium balance.
Measured: Day 1 and day 140
Change from baseline in aberrant behaviour checklist
A validated scale for use in autism
Measured: Day 1 and day 140
Change from baseline in cytokines
Serum will be analysed for specific cytokines
Measured: Day 1 and day 140
Change from baseline in autoimmune markers
Serum will be analysed for specific autoimmune markers
Measured: Day 1 and day 140
Change from baseline in behaviour Assessment System for Children - Second Edition
A validated scale for use in autism
Measured: Day 1 and day 140
Change from baseline in repetitive behavior Scale - Revised
A validated scale for use in autism
Measured: Day 1 and day 140
Change from baseline in Social Responsiveness Scale
A validated scale for use in autism
Measured: Day 1 and day 140
Change from baseline in Developmental Disabilities-Children's Global Assessment Scale
A clinical global impression of autism
Measured: Day 1 and day 140
Change from baseline in Vitamin D and Sun Questionnaire
A scale assessing behaviour related to vitamin D
Measured: Day 1 and day 140
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- The National Children's Hospital, Tallaght
- Responsible party
- Principal investigator, Conor Kerley, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508922
- Sponsor's protocol ID
- NCHVitDASD
- Status last verified
- Oct 2016
- First submitted
- 24 Jul 2015
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17920208Eyles 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.
PubMed 20219042Becker 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.
PubMed 21395563Kocovska 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.
PubMed 22522213Mostafa 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.
PubMed 22898564Cannell 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.
PubMed 23725905Cannell 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.
PubMed 24494055Patrick 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.
PubMed 24558199Jia 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.
PubMed 25511123Saad 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.
PubMed 25876214Kerley 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.
PubMed 28626020
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D3 for Autism Spectrum Disorder: a Randomized, Double-blind, Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT02508922
- Acronym / sponsor ID
- NCHVitDASD
- Conditions
- Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- The National Children's Hospital, Tallaght
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 27 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Experimental | Dietary Supplement: Vitamin D32000iu vitamin D will be taken daily for 20 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMatching placebo drops will be taken daily for 20 weeks |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Positive autism diagnostic observation schedule
- Stable medication regimen
- Tolerate phlebotomy
Key exclusion criteria (3 listed)
- Unstable or very severe autism
- Epilepsy
- Renal/liver/gastrointestinal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: cholecalciferol2,000iu vitamin D drops will be taken daily for 20 weeks | Dietary supplement | Vitamin D3 |
| PlaceboMatching placebo drops will be taken daily for 20 weeks | Dietary supplement | Placebo |
Primary outcome
Change from baseline in stereotypic behaviour from the aberrant behaviour checklist
Time frame: Day 1 and day 140
A subscale derived from the validated aberrant behaviour checklist
10 secondary outcomes
Change from baseline in serum 25-hydroxyvitamin D levels
Time frame: Day 1 and day 140
Change from baseline in serum calcium levels, corrected for albumin
Time frame: Day 1 and day 140
Change from baseline in aberrant behaviour checklist
Time frame: Day 1 and day 140
Change from baseline in cytokines
Time frame: Day 1 and day 140
Change from baseline in autoimmune markers
Time frame: Day 1 and day 140
Change from baseline in behaviour Assessment System for Children - Second Edition
Time frame: Day 1 and day 140
Change from baseline in repetitive behavior Scale - Revised
Time frame: Day 1 and day 140
Change from baseline in Social Responsiveness Scale
Time frame: Day 1 and day 140
Change from baseline in Developmental Disabilities-Children's Global Assessment Scale
Time frame: Day 1 and day 140
Change from baseline in Vitamin D and Sun Questionnaire
Time frame: Day 1 and day 140
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Background: PubMed 17920208Cannell JJ. Autism and vitamin D. Med Hypotheses. 2008;70(4):750-9. doi: 10.1016/j.mehy.2007.08.016. Epub 2007 Oct 24.
- Background: PubMed 20219042Eyles 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.
- Background: PubMed 21395563Becker 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.
- Background: PubMed 22522213Kocovska 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.
- Background: PubMed 22898564Mostafa 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.
- Background: PubMed 23725905Cannell 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.
- Background: PubMed 24494055Cannell 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.
- Background: PubMed 24558199Patrick 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.
- Background: PubMed 25511123Jia 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.
- Background: PubMed 25876214Saad 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.
- Derived from this study: PubMed 28626020Kerley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Autism, run by University of Dublin, Trinity College at 3 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in stereotypic behaviour from the aberrant behaviour checklist (time frame: Day 1 and day 140). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02508922, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.