Vitamin D Status in Autism Spectrum Disorder and the Efficacy of Vitamin D Supplementation in Autistic Children

UMIN ID: UMIN000016770

Registered date:01/04/2015

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Autism Spectrum Disorder
• Date of first enrollment: 2014/03/01
• Target sample size: 100
• Countries of recruitment: Africa
• Study type: Interventional,observational
• Intervention(s): vitamin D3 (300 IU/Kg/day not to exceed 5,000 IU/day

Outcome(s)

• Primary Outcome: We performed a case-controlled cross sectional analysis conducted on a 122 ASD children, to assess their vitamin D status compared to controls and the relationship between vitamin D deficiency and the severity of autism. We also conducted an open trial of vitamin D supplementation in ASD children. Fifty-seven % of the patients in the present study had vitamin D deficiency, and thirty % had vitamin D insufficiency. The mean 25-OHD levels in patients with severe autism were significantly lower than those in patients with mild/moderate autism. Serum 25-OHD levels had significant negative correlations with CARS scores.
• Secondary Outcome: Of the ASD group, 106 patients with low serum 25-OHD levels (<30 ng/ml) participated in the open label trial. They received 5000 IU/day of vitamin D3 for three months. Eighty-three subjects completed three months of daily vitamin D treatment. Collectively 80.72% (67/83) of subjects who received vitamin D3 treatment had significantly improved outcome, which was mainly in the sections of the CARS that measure behavior, eye contact and attention span.

Key inclusion & exclusion criteria

• Age minimum: 3years-old
• Age maximum: 9years-old
• Gender: Male and Female
• Exclude criteria: children with feeding problems or malnutrition were excluded from the study. Subjects who had associated gastrointestinal problems, autoimmune disorders, anemia, neurological diseases (such as cerebral palsy and tuberous sclerosis) and metabolic disorders (e.g. phenylketonuria) as well as any subjects receiving vitamin D containing preparations and drugs that may affect vitamin D (e.g. steroid and antiepileptics) were excluded.

Related Information

• Primary Sponsor: Council for Nutritional and Environmental Medicine (CONEM).
• Source(s) of Monetary Support: No funding was secured for this study.