The Role of Dietary Calcium for the Treatment of Osteopenia in Girls With Rett Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Bone mineral content (BMC)
研究概览
简要总结
Randomized, placebo-controlled trial of oral calcium supplementation for osteopenia in girls and women with Rett syndrome
详细描述
Objective
The investigators conducted a randomized, double-blind, placebo-controlled trial to determine the safety and efficacy of oral calcium supplementation for the treatment of bone mineral deficits in individuals with Rett syndrome (RTT).
Methods: The investigators measured total body bone mineral content (BMC) and bone mineral density (BMD) by dual-energy x-ray absorptiometry and biomarkers of bone turnover by clinical laboratory techniques before and one year after oral calcium or placebo supplementation in 32 pre- and post-pubertal girls and young women with RTT. The calcium supplement was calculated to provide a twofold increase in the recommended dietary allowance of calcium for age.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Years 至 30 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Bone mineral content (BMC)
时间窗: change from baseline to 1 year thereafter
Bone mineral content (z-score) measured by dual-energy x-ray absorptiometry
Bone mineral density (BMD)
时间窗: change from baseline to 1 year thereafter
Bone mineral density (z-score) measured by dual-energy x-ray absorptiometry
次要结局
- C-telopeptide(change from baseline to 1 year thereafter)
- Osteocalcin(change from baseline to 1 year thereafter)
- Calcium/creatinine ratio(change from baseline to 1 year thereafter)
- Bone alkaline phosphatase(change from baseline to 1 year thereafter)
研究者
Kathleen J Motil
Professor
Baylor College of Medicine