Effect of vitamin D in autism spectrum disorder: A clinical trial
- Conditions
- Health Condition 1: F840- Autistic disorder
- Registration Number
- CTRI/2019/09/021079
- Lead Sponsor
- ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Newly diagnosed patients with autism spectrum disorder
2.All consecutive children between age 3-8 years attending the Child Psychiatry Clinic, JIPMER hospital, with a diagnosis of Autism Spectrum Disorder as per DSM 5
1.Patient on vitamin D-based therapy within 6 months prior to screening.
2.Patients with symptomatic vitamin D deficiency
3.Patient with a history of allergy or sensitivity to vitamin D or its analogues.
4.Patients with coexisting diseases, such as, chronic gastrointestinal disease, myocardial infarction, cerebrovascular accident, congestive heart failure, cardiomyopathies, peripheral vascular diseases, malignancies and renal stones.
5.Patient has received any investigational drug <= 3 months prior to this study.
6.Patient on any drugs modulating calcium metabolism and homeostasis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy of combination therapy of oral vitamin D supplementation and parent-mediated behavioral interventions to parent-mediated behavioral interventions and placebo for three months in children (4-12 years) with autism spectrum disorder using CARS 2 (Childhood autism rating scale)Timepoint: 3months
- Secondary Outcome Measures
Name Time Method To generate the frequency of VDR gene polymorphisms [ApaI (rs7975232), BsmI (rs1544410), TaqI (TC; rs731236), FokI (CT; rs2228570)] in children with autism spectrum disorder and to evaluate their effect on response to vitamin D therapyTimepoint: 3 months