Comparison of supplementation with two different doses of vitamin D on bone mineral density in patients with Duchenne muscular dystrophy- A randomised double blind control trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Bone mineral density
研究概览
简要总结
Patients with DMD are prone to loss of bone mass, osteoporosis and fractures of long bones and vertebrae.
There is some evidence that supplementation with Vitamin D improves the status of bone mineralisation in DMD patients,
improves mobility and prevents fractures. Investigators have given different doses as indicated in the published literature, however,
the optimum supplementary dose is not known.
This study will be conducted to compare the bone mineral density and some clinical indicators of mobility after supplementation with 2 different
doses of Vitamin D3 for a period of 6 months.
We hypothesise that supplementation with the higher dose of 4000 units per day for 6 months will improve the outcome measures more than
suppkementation with 1000 units per day for a period of 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patients with confirmed diagnosis of DMD with serum Vitamin D level < 75 nanomol/L.
排除标准
- •Patients with other forms of muscular dystrophy
- •Boys with joint contractures and/or severe kyphoscoliosis
- •Inability to stand upright.
结局指标
主要结局
Bone mineral density
时间窗: 0 months | 6 months
次要结局
- Mean change in 6 minute walk distance, time taken to rise from floor, change in Vignos functional scale grading(0 months)