NCT00870961终止不适用
Vitamin D Intervention For Colon Cancer Prevention In African-Americans-A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Rate of compliance as assessed at 6 months
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of vitamin D may keep colorectal cancer from forming in patients with colon polyps.
PURPOSE: This randomized phase I trial is studying a vitamin D supplement to see how well it works compared with a placebo in preventing colorectal cancer in African Americans with colon polyps.
详细描述
OBJECTIVES:
Primary
- To determine the accrual rate of African Americans with adenomatous polyps to a 6-month randomized intervention trial comprising supplementation with either cholecalciferol (vitamin D3) or placebo.
- To determine the compliance rates in patients treated with these regimens.
Secondary
- To compare changes in pre- and post-treatment vitamin D levels in patients treated with these regimens.
- To correlate vitamin D levels with vitamin D modifiers, such as levels of skin pigmentation, dietary vitamin D intake, and sun exposure in this patient population.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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
Rate of compliance as assessed at 6 months
时间窗: Following 6 months of study treatment
Rate of accrual
时间窗: After accrual goal is reached
次要结局
- Correlation of vitamin D levels with vitamin D modifiers (e.g., levels of skin pigmentation, dietary vitamin D intake, and sun exposure)(After completion of study treatment & final colonic biopsy)
- Changes in pre- and post-treatment vitamin D levels(At baseline and following completion of study treatment)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
2 期
Efficacy of Vitamin D in Colorectal Cancer ChemopreventionColorectal CancerNCT01574027University of Illinois at Chicago55
已完成
3 期
High-Dose Multivitamins Compared to a Placebo in Preventing the Recurrence of Cancer in Patients With Early Stage Bladder CancerBladder CancerNCT00003623Alliance for Clinical Trials in Oncology21
已完成
3 期
Diindolylmethane in Treating Patients With Abnormal Cervical CellsPrecancerous ConditionCervical CancerNCT00462813Barts and the London School of Medicine and Dentistry3,000
已完成
3 期
S0000 Selenium and Vitamin E in Preventing Prostate CancerProstate CancerNCT00006392SWOG Cancer Research Network35,533
Unknown
2 期
Study of Calcium Plus Vitamin D Supplementation in Prevention of Colorectal Adenomas RecurrenceColorectal AdenomaNCT02143505Shanghai Jiao Tong University School of Medicine900