None listed
Conditions
Interventions
Intervention1: Vitamin D: Intervention group - an oral dose of Vitamin D of 4000 IU per day, to be given as once a month dose.
Control Intervention1: Vitamin D: Control group- an oral dose of Vitamin
Sponsors
AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: ? Are in obesity group - as per age and sex specific BMI cutoff as suggested by International Obesity Task Force (IOTF).
Exclusion criteria
Exclusion criteria: ? Have past or current history or family history of renal stones. ? Already diagnosed with diabetes (type 1 or 2) as per American Diabetes Association (ADA) criteria. ? Are taking metformin or any other drug affecting insulin resistance or taking any drug for weight reduction. ? Are taking or had taken vitamin D supplementation in last six months in doses exceeding 400 IU/day ? Have any systemic disease (cardiac, hepatic, endocrine or renal) or taking any kind of treatment more than one month in last six months. ? Are diagnosed malabsorption (celiac disease, Crohn?s dis, ulcerative colitis) or history suggestive of malabsorption. ? Are using medications known to interact with vitamin D metabolism (steroids, thiazide diuretics, phenytoin, phenobarbitone, and antitubercular drugs) ? Have known hypersensitivity to vitamin D preparation ? Have participated in any other investigational drug study in previous three months ? Have features suggestive of osteomalacia or severe vitamin D deficiency ? Have past history of bariatric surgery ? Are using Ultra-Violet (UV) radiations as a part of medical therapy ? Are diagnosed with albinism or have other condition associated with decreased skin pigmentation ? Have any medical condition that in the judgment of the investigator would jeopardize the subject?s safety or evaluation of study drug for efficacy or safety. ? Are not willing to come for follow-up ? Have serum calcium more than 1 mg/dL above the upper limit of normal for age ? Have hypercalciuria as per definition ? Have serum 25-hydroxy vitamin D level more than 100 ng/mL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures: (1) Changes in insulin resistance as measured by Homeostatic Model Assessment (HOMA, Fasting blood glucose x Fasting C-peptide divided by 22.5), one year after randomization. (2) Changes in beta cell function as measured by ?Disposition Index" (calculated by the insulin secretion x insulin sensitivity) one year after randomization.Timepoint: Measurement of outcome measures before and one year after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures Change in following parameters after one year in subjects who received vitamin D in supplemental doses in comparison with subjects receiving vitamin D in doses of 400 IU/day. Cardiovascular risk factors (a) Biochemical - C reactive protein (CRP), Interleukin-6 (IL-6) and Tumor necrosis factor-alpha (TNF-alpha) (b) Radiological cardiovascular risk factors - aortic pulse wave velocity (AoPWV) and Augmentation index (AI) by radial pulse wave analysis. Timepoint: Before and one year after randomization | — |
Countries
India
Contacts
Public ContactRajesh Khadgawat
Outcome results
None listed