Effects of Oral Cholecalciferol (Vitamin D3) on Bone Health, Neuromuscular Function, and Quality of Life in Adults With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- change in physical performance score
研究概览
简要总结
Will oral vitamin improve strength, bone quality, pain and quality of life. This is a double blind, randomized placebo controlled study using 10,000 IU of cholecalciferol vs placebo.
详细描述
The proposed study is be a randomized, double-blind, placebo-controlled trial of supplementation with oral vitamin D3.
Each subject will take a once-weekly capsule containing vitamin D3 or a an identical-appearing placebo for a treatment period of 15 weeks.
Subjects will be assessed for Bone pain and tenderness, Neuromuscular function, physical performance score, and Quality of life assessment.
A subset of subjects will have bone biopsies performed before and after intervention.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On dialysis
- •Likely to be able to complete the study
- •At least minimally ambulatory, with or without a walking aid (i.e., cane or walker)
- •Able to complete the various questionnaires interactively with the research nurse
- •Venous access that can be accomplished without unusual difficulty.
排除标准
- 未提供
结局指标
主要结局
change in physical performance score
时间窗: 15 weeks
次要结局
- Bone pain and tenderness(15 weeks)
- Neuromuscular function tests(15 weeks)
- Quality of life assessment(15 weeks)
研究者
Laura Armas
Assistant Professor
Creighton University