Using Ca-41 Methodology to Assess the Impact of Different Vitamin D Supplementation Levels on Postmenopausal Bone Health
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- urinary Ca-41/Ca-40 ratio
研究概览
简要总结
The purpose of this study is to determine whether increasing levels of serum 25(OH)Vitamin D as achieved by oral supplementation higher than the current recommendations are associated with a less negative bone calcium balance in post-menopausal Swiss women.
详细描述
In a substudy - not related to the vitamin D intervention - spot and 24 h urine samples are compared with regard to the assessment of iodine status in Swiss post-menopausal women.
In an short subsequent study using five of the subjects who participated in the original trial, the effect of a 40 d-exercise program (rebounding on a trampoline) on Ca-41 excretion will be observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •apparently healthy women, at least 5 years post-menopausal
- •BMI 18-30
- •no regular intake of Ca or vit D supplements
- •wiling and able to give written informed consent and to understand, participate and comply with study requirements
- •non-smokers
- •no long travels (>3 wk) planned within study period
排除标准
- •diseases that predispose to osteoporosis
- •history of fragility fractures
- •currently on a weight reduction program
- •excessive physical activity
- •diseases influencing calcium metabolism (thyroid, parathyroid, adrenal disorders etc.)
- •regular intake of medication affecting calcium metabolism
- •osteoporosis (T-score below -2.5)
- •history of psychological illness likely to interfere with the subject's ability to understand the requirements of the study
- •participation in concurrent studies
结局指标
主要结局
urinary Ca-41/Ca-40 ratio
时间窗: March 2010 to January 2011
次要结局
- biomarkers of bone metabolism(March 2010 to January 2011)
- urinary iodine(August 2009 to December 2010)
研究者
Prof. Michael B. Zimmermann
Prof. Dr. med
Swiss Federal Institute of Technology