NCT01631292已完成不适用
A Pilot Dose Response Study to Vitamin D in Obesity and Weight Loss: Effect on Bone
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Bone mineral density (BMD)
研究概览
简要总结
In this study, we will provide supplemental vitamin D in postmenopausal overweight/obese women, and hypothesize that it will not affect areal BMD, but will alter bone compartments (trabecular and cortical bone). In addition, higher vitamin D intake will increase serum 25OHD and suppress serum PTH and bone turnover during weight reduction. Secondary outcomes include the influence of vitamin D and weight loss on markers of insulin resistance and on cognitive tests of attention, learning, and memory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 72 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Body mass index of 25-40 kg/m2
- •Postmenopausal
- •Age 50-72 years
排除标准
- •Women who are taking any medication known to influence Calcium or bone metabolism,
- •Evidence of diseases known to influence Calcium metabolism (i.e. metabolic bone disease)
- •hyperparathyroidism
- •untreated thyroid disease
- •significant immune disease
- •hepatic disease
- •renal disease or a kidney stone in the last 5 years
- •significant cardiac disease
- •active malignancy or cancer therapy within the past year
结局指标
主要结局
Bone mineral density (BMD)
时间窗: 1 year
BMD
Bone quality
时间窗: 1 year
thickness (mm)
次要结局
- cholesterol absorption(baseline and one year)
- Cognition and biochemical markers(One year)
- serum vitamin D(Baseline, 6 months and 12 months)
- Bone turnover markers(Baseline, 6 months, 12 months)
- Glycemic indices(Baseline, 6 months and 12 months)
- Bone regulating hormones(Baseline, 6 months and 12 months)
研究者
Sue A. Shapses, Ph.D., RD
Professor
Rutgers University
研究点 (2)
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