Health Condition 1: null- GradeI obese
Conditions
Interventions
Intervention1: vitamin D sachet: CHOLECALIFEROL
MODE-ORALLY
1,20,000 IU-ONCE IN A MONTH FOR SIX MONTHS
Control Intervention1: PLACEBO: INERT LACTOSE
Sponsors
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
Eligibility
Inclusion criteria
Inclusion criteria: Obese adolescents (11-18yrs) â?? as per age and sex specific BMI cutoff by International Obesity Task Force (IOTF) Adults(19-40yrs)- BMI-30 to 35 kg/m2
Exclusion criteria
Exclusion criteria: Subjects on vitamin D supplementation from last three months Subjects with clinical vitamin D deficiency Subjects on any other weight management program in last 12 months Self reported/previously diagnosed renal and hepatic disorder Diabetic patients (Fasting plasma glucose > 126mg/dL) Malabsorption Syndrome (Celiac disease, Crohnâ??s disease) Chronic alcoholic/smokers • Pregnant women • Medication (e.g. metformin, steroids, thiazide diuretics, phenytoin, phenobarbitone, ATT) Hypercalcaemia Albinism or condition associated with decreased skin pigmentation History of hypersensitivity to vitamin D
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in β- cell functions as measured by disposition index.Timepoint: Baseline, at 3 month and 6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes in Vitamin D level as measured serum 25(OH) D3 2) Changes in serum adipocytokines levels (IL-6, TNF- α, leptin, adiponectin) 3) Changes in Body fat distribution- DXA 4) Changes in cognitive domainsTimepoint: (1-3) Baseline, at 3 month and 6 month (4)Baseline and after 6 month | — |
Countries
India
Contacts
Public ContactDR RAJ KUMAR YADAV
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed