Health Condition 1: F840- Autistic disorder
Conditions
Interventions
Intervention1: Oral vitamin D 60,000 IU: Oral vitamin D 60,000 IU once in 2 weeks + parent mediated interventions for 12 weeks
(60000IU Oral Vit D sachets once in 14 days for 12 weeks)
Control Interv
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 6.Patient on any drugs modulating calcium metabolism and homeostasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactSandhiya S
JIPMER
Outcome results
None listed