Autism
Conditions
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.
Interventions
DIETARY_SUPPLEMENTVitamin D3
2,000iu vitamin D drops will be taken daily for 20 weeks
DIETARY_SUPPLEMENTPlacebo
Matching placebo drops will be taken daily for 20 weeks
Sponsors
The National Children's Hospital, Tallaght
University of Dublin, Trinity College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Positive autism diagnostic observation schedule * Stable medication regimen * Tolerate phlebotomy
Exclusion criteria
* Unstable or very severe autism * Epilepsy * Renal/liver/gastrointestinal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in stereotypic behaviour from the aberrant behaviour checklist | Day 1 and day 140 | A subscale derived from the validated aberrant behaviour checklist |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in serum calcium levels, corrected for albumin | Day 1 and day 140 | Total serum calcium levels indicating calcium balance. |
| Change from baseline in aberrant behaviour checklist | Day 1 and day 140 | A validated scale for use in autism |
| Change from baseline in cytokines | Day 1 and day 140 | Serum will be analysed for specific cytokines |
| Change from baseline in autoimmune markers | Day 1 and day 140 | Serum will be analysed for specific autoimmune markers |
| Change from baseline in serum 25-hydroxyvitamin D levels | Day 1 and day 140 | Total vitamin D levels |
| Change from baseline in repetitive behavior Scale - Revised | Day 1 and day 140 | A validated scale for use in autism |
| Change from baseline in Social Responsiveness Scale | Day 1 and day 140 | A validated scale for use in autism |
| Change from baseline in Developmental Disabilities-Children's Global Assessment Scale | Day 1 and day 140 | A clinical global impression of autism |
| Change from baseline in Vitamin D and Sun Questionnaire | Day 1 and day 140 | A scale assessing behaviour related to vitamin D |
| Change from baseline in behaviour Assessment System for Children - Second Edition | Day 1 and day 140 | A validated scale for use in autism |
Countries
Ireland
Outcome results
None listed