Trial of Vitamin D3 Supplementation in Paediatric Autism

University of Dublin, Trinity College

Status: Completed

Conditions: Autism

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT02508922

NCHVitDASD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

Vitamin D3

Experimental group

Description:

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

Treatment:

Dietary Supplement: Vitamin D3

Placebo

Placebo Comparator group

Description:

Matching placebo drops will be taken daily for 20 weeks

Treatment:

Dietary Supplement: Placebo