Public title of studyA Study Evaluating the Effect of Vitamin D Supplementation on Beta Cell Function and Insulin Resistance in Obese Asian-Indian Children Aged 11-17 years.
- Registration Number
- CTRI/2011/04/001699
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 320
?Are in obesity group - as per age and sex specific BMI cutoff as suggested by International Obesity Task Force (IOTF).
?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/m
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method