Study of Serum 25(OH) D3 Level Variability in Response to Different Doses of Oral Vitamin D Supplementation in Prostate Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •25(OH) D3 level < 80 ng/mL
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •ECOG performance status 0-2
- •Creatinine ≤ 2.0 mg/dL
- •Corrected serum calcium ≤ 10.5 mg/dL
排除标准
- •History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue)
- •Hypersensitivity to cholecalciferol or one of its components
- •PRIOR CONCURRENT THERAPY:
- •No other concurrent vitamin D supplementation
研究组 & 干预措施
Arm IV
Patients receive 10,000 IU of vitamin D3 once daily.
干预措施: cholecalciferol (Dietary Supplement)
Arm I
Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
干预措施: cholecalciferol (Dietary Supplement)
Arm III
Patients receive 8,000 IU of vitamin D3 once daily.
干预措施: cholecalciferol (Dietary Supplement)
Arm II
Patients receive 6,000 IU of vitamin D3 once daily.
干预措施: cholecalciferol (Dietary Supplement)
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)