Effect of Calcium and Vitamin D Supplements and/or Prunes on Bone Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Changes from baseline in bone mineral density at 12 and 24 months
研究概览
简要总结
The objective of this study is to examine if calcium and vitamin D supplements and/or prune can prevent bone loss in postmenopausal women.
详细描述
Two hundred randomly assigned to one of two treatment groups: 1) 30 g prunes and 2) control (0 g prunes). Both groups received 500 mg calcium and 400 IU Vitamin D as a daily supplement. Blood samples are collected at baseline, 12 and 24 months to assess biomarkers of bone turnover. Physical activity recall and food records are obtained at baseline, 12 and 24 months to examine physical activity and dietary confounders as potential covariates. Dual-energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) will be completed at baseline, 12 and 24 months to examine bone mineral density and structure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal
- •BMD t-score is between 0.5 and 2 SD below the mean
- •Not on hormone replacement therapy (HRT) and/or other pharmacological agents known to affect bone for at least three months prior to initiation of the study
排除标准
- •Women whose BMD t-score at any site falls below 2.5 SD of the mean
- •Subjects receiving endocrine (e.g., prednisone, other glucocorticoids) or neuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism
- •Subjects who smoke cigarettes or vape
- •Regular consumption of dried plum or prune juice
研究组 & 干预措施
30 g prune/day
Participants receive 500 mg calcium and 400 IU vitamin D daily for 24 months and 30 g of prune daily for 24 months.
干预措施: Prune (Dietary Supplement)
Control (0 g prune/day)
Participants only receive 500 mg calcium and 400 IU vitamin D daily for 24 months.
结局指标
主要结局
Changes from baseline in bone mineral density at 12 and 24 months
时间窗: Baseline, 12 months, and 24 months
bone mineral density as assessed by dual energy x-ray absorptiometry
次要结局
- Changes from baseline in bone specific alkaline phosphatase at 12 months and 24 months(Baseline, 12 months, and 24 months)
- Changes from baseline in tartrate acid phosphatase-5b at 12 months and 24 months(Baseline, 12 months, and 24 months)
研究者
Shirin Hooshmand
Professor
San Diego State University