Defining Optimal Doses of Vitamin D for Chemoprevention in Blacks.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months.
研究概览
简要总结
This study will help us know the effects of Vitamin D pills in Blacks. The results of this study may be the first step in creating ways to prevent the risks of colon and prostate cancer. It will also help us develop ways to reduce colon cancer and prostate cancer among Blacks. This study will find out if Vitamin D pills can increase Vitamin D to healthy levels in our bodies.
详细描述
- Participants will be asked to answer some questions about their diet, exercise and health. In addition, participants blood pressure will be taken. These assessments will occur at baseline, 3- and 6-month appointments. At baseline only, we will measure skin tone with a tool called the Photovolt 577.
- A small blood sample will be taken to see how much Vitamin D is the body and will also look at levels of other markers of disease such as proteins, hormones, and genes.
- Participants will take a vitamin pill every day for three months and be randomly assigned to one of four different types of pills.
- Participants will be called or visited at least every two weeks. They will be asked questions to determine if they have any side effects associated with high levels of Vitamin D.
- At the beginning of the second and third months, participants will be provided with more pills. At the end of the third month, another blood sample will be taken. Three months after that, the final blood sample will be taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 30 and 80 years
- •Comfortable communicating in English
- •Currently has a primary care physician
- •Willing to discontinue vitamin D or calcium supplements
- •Willing to have all protocol specific tests run
排除标准
- •Plans on taking a vacation or travel to a sunny region within 3 months of vitamin supplementation period except for a short period (i.e. 1 weekend)
- •Pregnant or breast feeding or planning on becoming pregnant in the following year
- •Pre-existing calcium (including hypercalcemia), parathyroid conditions (including hyperparathyroidism), sarcoidosis
- •No concurrent active malignancies (other than non-melanoma skin cancer) or previous diagnosis of prostate cancer
- •Cognitively impaired
- •Active thyroid disease (e.g. Graves, Hashimoto's or thyroiditis)
- •History of nephrolithiasis, chronic liver disease, chronic renal disease, or renal dialysis
研究组 & 干预措施
2
1000 IU of Vitamin D
干预措施: Vitamin D (Drug)
3
2000 IU of Vitamin D
干预措施: Vitamin D (Drug)
1
No Vitamin D
干预措施: Placebo (Dietary Supplement)
4
4000 IU of Vitamin D
干预措施: Vitamin D (Drug)
结局指标
主要结局
Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months.
时间窗: Baseline, 3months, 6months
Among Blacks, identify a dose of oral vitamin D supplementation that will result in levels of plasma 25(OH)D that would be predicted to reduce colorectal cancer incidence. Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.
次要结局
- Change in IL-10 From 0 to 3 Months.(From baseline to 3 months)
- Change in sTNF-R2 From 0 to 3 Months.(From baseline to 3 months)
- Change in CRP From 0 to 3 Months.(From baseline to 3 months)
- Change in IL-6 From 0 to 3 Months.(From baseline to 3 months)
研究者
Kimmie Ng, MD
Principal Investigator
Dana-Farber Cancer Institute