CTRI/2011/04/001699尚未招募未知
A Randomized Double Blind Controlled Trial to Investigate the Effects of Vitamin D supplementation on Insulin Resistance and Beta cell function in obese Asian-Indian Subjects, aged 11-17 years.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- AIIMS
- 入组人数
- 320
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •?Are in obesity group - as per age and sex specific BMI cutoff as suggested by International Obesity Task Force (IOTF).
排除标准
- •?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
研究者
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