Trial of Vitamin D3 Supplementation in Paediatric Autism

• Register: ClinicalTrials.gov
• Last refreshed on: 7 November 2016
• Main ID: NCT02508922
• Date of registration: 24/07/2015
• Prospective Registration: Yes
• Primary sponsor: University of Dublin, Trinity College
• Public title: Trial of Vitamin D3 Supplementation in Paediatric Autism
• Scientific title: Vitamin D3 for Autism Spectrum Disorder: a Randomized, Double-blind, Placebo-controlled Trial.
• Date of first enrolment: September 2015
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02508922
• Study type: Interventional
• 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
• Phase: N/A

Countries of recruitment

Ireland

Key inclusion & exclusion 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



Age minimum: 3 Years
Age maximum: 12 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Autism

Intervention(s)

Dietary Supplement: Vitamin D3

Dietary Supplement: Placebo

Primary Outcome(s)

Change from baseline in stereotypic behaviour from the aberrant behaviour checklist [Time Frame: Day 1 and day 140]

Secondary Outcome(s)

Change from baseline in aberrant behaviour checklist [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 cytokines [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 Vitamin D and Sun Questionnaire [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 Developmental Disabilities—Children's Global Assessment Scale [Time Frame: Day 1 and day 140]

Change from baseline in serum 25-hydroxyvitamin D levels [Time Frame: Day 1 and day 140]

Change from baseline in autoimmune markers [Time Frame: Day 1 and day 140]

Secondary ID(s)

NCHVitDASD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The National Children's Hospital, Tallaght