NCT01224678已完成3 期
Vitamin D and Breast Cancer Biomarkers
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 204
- 主要终点
- Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms
研究概览
简要总结
RATIONALE: Vitamin D may help prevent breast cancer.
PURPOSE: This randomized clinical trial is studying vitamin D and breast cancer biomarkers in female patients.
详细描述
OBJECTIVES:
Primary
- To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women.
Secondary
- To explore changes in the serum biomarker IGF1 in response to one year of vitamin D or placebo supplementation in premenopausal women.
- To explore changes in cellular proliferation (atypia and Ki67) in response to one year of vitamin D or placebo supplementation in premenopausal women.
- To explore correlations between change in breast cancer biomarkers (density, IGF1, atypia, and Ki67) with each other and with change in vitamin D levels.
- To compare methods of mammographic density analysis.
- To validate a recently developed sunlight questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo Comparator
Patients receive oral placebo once daily for 12 months.
干预措施: placebo (Other)
Vitamin D
Experimental
Patients receive oral vitamin D (2000 IU) once daily for 12 months.
干预措施: vitamin D (Dietary Supplement)
结局指标
主要结局
Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms
时间窗: 12 months
To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women. The percent change in breast density will be reported here.
次要结局
未报告次要终点
研究者
研究点 (204)
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