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临床试验/NCT00994396
NCT00994396已完成不适用

Use of Vitamin D to Improve Glucose Metabolism and Reduce Inflammation in Obese Adolescents on a Standard Weight Loss Program

University of Missouri-Columbia2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
serum 25-hydroxy vitamin D concentrations

研究概览

简要总结

The investigators' project will study the effects of optimizing the vit D status of obese adolescents on markers of glucose metabolism and inflammation.

详细描述

The alarming rise in pediatric obesity over the past few decades has been associated with an increase in the occurrence of impaired glucose tolerance and inflammation in children and adolescents. These conditions are part of the "metabolic syndrome", and children with risk factors such as these are much more likely to develop cardiovascular disease or diabetes as adults compared with their lean peers. Within the last few years there has been a growing body of evidence that optimizing vitamin D (vit D) status may alleviate these obesity-associated complications. Further, there is also research that shows that the better the vit D status of overweight individuals, the more favorably they respond to dieting by losing more body fat. The prevalence of vit D deficiency/insufficiency in the North American population has been classified as an "epidemic" by experts in the field and obese teens are considered at an even greater risk for deficiency because they tend to store vit D in their fat stores which is not readily mobilized for use by the body. The investigators' project will study the effects of optimizing the vit D status of obese adolescents on markers of glucose metabolism and inflammation. Obese teens attending an established adolescent weight loss clinic will be supplemented with high-dose vit D for 6 months (mos) which will be administered concurrently with their standard medical care and treatment. At baseline, 3 mos and 6 mos the investigators will measure vit D status, serum markers of insulin sensitivity and glucose metabolism; serum markers of inflammation; and body weight/height and waist circumference. At baseline and 6 mos only the investigators also measure body composition (percent body fat by dual-energy x-ray absorptiometry) and confounding lifestyle factors known to affect vit D, glucose metabolism or inflammation (e.g., nutrient intake, physical activity, sun exposure, pubertal stage). Results gleaned from this study will help to advance the prevention and treatment of obesity-related complications and have the potential to lead to significant reductions in healthcare costs and co-morbidities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
9 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Obese adolescent (BMI > 85th percentile for age)
  • 9-19 years of age
  • attending the ADOBE clinic at the University of Missouri

排除标准

  • use of vit D supplements other than standard multi-vitamin preparation
  • (i.e., should not be receiving vit D > 1000 IU/d) use of medications that interfere with vit D metabolism (e.g., anti-convulsive)
  • history of hepatic or renal disorders;
  • undergoing ultraviolet radiation as medical therapy;
  • pregnancy;
  • cigarette smoking;
  • current use of commercial tanning bed;

结局指标

主要结局

serum 25-hydroxy vitamin D concentrations

时间窗: baseline, 3, 6 months

serum concentrations of inflammatory markers (Interleukin-6, TNF-alpha, c reactive protein)

时间窗: baseline and 6 mos

Hemoglobin A1C, serum glucose and insulin concentrations

时间窗: baseline, 3 and 6 months

次要结局

  • Body composition as measured by DXA(baseline and 6 mos)
  • Body mass index(baseline, 3 and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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