NCT00524680已完成2 期
Study of Serum 25(OH) D3 Level Variability in Response to Different Doses of Oral Vitamin D Supplementation in Prostate Cancer Patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Pattern of Response of Serum 25(OH) D3 Levels
研究概览
简要总结
RATIONALE: Vitamin D may be effective in treating patients with prostate cancer.
PURPOSE: This randomized phase II trial is studying how well 4 different doses of vitamin D works in treating patients with prostate cancer.
详细描述
OBJECTIVES:
Primary
- To examine the pattern of response of serum 25(OH) D3 levels following cholecalciferol (vitamin D3) supplementation at four different oral doses in patients with prostate cancer.
Secondary
- To examine the pattern of response of parathormone (PTH) following vitamin D3 supplementation in these patients.
- To assess the toxicity of vitamin D3 supplementation in men with prostate cancer.
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
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 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
Pattern of Response of Serum 25(OH) D3 Levels
时间窗: Baseline, at 1, 3, 6 months
Change from Baseline in Serum 25(OH) D3 Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.
次要结局
- Toxicity(Baseline, at 1, 3 and 6 months)
- Pattern of Response of Parathormone(Baseline, at 1, 3, 6 months)
- Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls(Baseline, at 1, 3 ,6 months)
研究者
研究点 (2)
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