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
- •clinical diagnosis of Rett syndrome
排除标准
- •parathyroid disease
- •renal disease
研究组 & 干预措施
Rett Placebo Supplement
Females with clinical diagnosis of Rett syndrome treated orally daily with sodium bicarbonate, dose based on equivalent weight for active supplement for age, for one year
干预措施: placebo (Dietary Supplement)
Rett Active Supplement
Females with clinical diagnosis of Rett syndrome treated orally daily with calcium carbonate, dose based on Dietary Reference Intake for age, for one year
干预措施: calcium (Dietary Supplement)
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