跳至主要内容
临床试验/NCT00288873
NCT00288873已完成4 期

Characterization of Hyperparathyroidism and Vitamin D Deficiency in Obesity

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年2月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Parathyroid hormone (PTH):iPTH and 3rd generation RIA

研究概览

简要总结

Obese persons are known to have elevated levels of parathyroid hormone (PTH) and low levels of vitamin D. These hormones are important in regulation of the body's calcium stores and bone health. We would like to investigate these abnormalities and the accuracy of our current diagnostic tests by comparing results of standard assays for vitamin D and PTH to more specific tests, in obese subjects at baseline and as vitamin D is replaced. We will also compare two standard vitamin D replacement regimens to determine if one is more effective.

This is a pilot study with two parts: Part 1 will compare levels of PTH and vitamin D using two different assays in obese subjects who have normal vitamin D and those who do not. We plan to enroll 20 subjects who have normal vitamin D levels and 40 subjects who have vitamin D insufficiency. All subjects will fill out questionnaires about the amount of calcium and vitamin D in their diet, and their recent sunlight exposure. We will ask for blood samples so that we can measure levels of calcium, vitamin D, albumin, creatinine, glucose, insulin and the different forms of PTH.

Subjects who have vitamin D insufficiency will then be randomized to receive Vitamin D2 or Vitamin D3 in standard doses for eight weeks, in an open label trial. At four and eight weeks, these subjects will fill out the above questionnaires and have the blood tests repeated. For safety purposes, urine calcium will also be monitored.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Obese subjects with body mass indices greater than 40 kg/m2 or 35 kg/m2 with other medical conditions secondary to obesity
  • Willingness to take vitamin D supplements
  • If baseline vitamin D level is >25 ng/ml subjects will be eligible for the control group
  • If baseline vitamin D level is <25 ng/ml subjects will be eligible for one of the two vitamin D replacement groups

排除标准

  • Hypercalcemia
  • Kidney disease
  • Liver disease
  • Malabsorption
  • Prior diagnosis of bone disease
  • Medical conditions requiring daily use of calcium, antacids, or medications known to affect bone metabolism or interact with vitamin D
  • Hypersensitivity to any formulation of vitamin D

结局指标

主要结局

Parathyroid hormone (PTH):iPTH and 3rd generation RIA

Vitamin D (25OHD):RIA and HPLC

次要结局

  • Ratio of PTH (1-84) to PTH (7-84)
  • Parathyroid hormone carboxy terminal fragment levels PTH(7-84)
  • Serum calcium level
  • Urine calcium level

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验