Clinical Trial of Vitamin D3 to Reduce Cancer Risk in Postmenopausal Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2,303
- 试验地点
- 2
- 主要终点
- all-type cancer (excluding non-melanoma skin cancers)
研究概览
简要总结
To determine the effect of increasing serum 25(OH)D from prevailing levels with vitamin D3 supplementation, while maintaining adequate calcium intake, on incidence of all-type cancer in a population sample of healthy postmenopausal women.
详细描述
Hypotheses:
Primary: Increasing serum 25(OH)D from prevailing levels with vitamin D3 supplementation, while maintaining adequate calcium intake, will significantly decrease incidence of all-type cancer in a population sample of healthy postmenopausal women.
Secondary:
- Increasing serum 25(OH)D from prevailing levels will significantly decrease incidence of specific cancers: breast, lung, colon, myeloma, leukemia, lymphoma.
- Increasing serum 25OHD from prevailing levels will significantly decrease incidence of other disorders, specifically hypertension, cardiovascular disease, osteoarthritis, colonic adenomas, diabetes, upper respiratory infections and falls.
Specific Aims:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: ≥ 55 years
- •Last menstrual period (LMP): ≥ 4 years
- •Good general health
- •Willingness to participate in this 4 year long study
- •Able to give informed consent
- •Able to live independently and travel to the Fremont Area Medical Center (FAMC) for study visits
排除标准
- •History of cancer except
- •Superficial basal or squamous cell carcinoma of the skin
- •Other malignancies treated curatively more than 10 years ago
- •History of renal calculi or chronic kidney disease
- •History of sarcoidosis
- •History of tuberculosis
- •Participation in the previous Creighton cancer prevention study
- •Mini-Mental Status Exam (MMSE) score of ≤
- •Use the MMSE if there are any concerns about the person's cognitive abilities or ability to give fully informed consent to the study. Concerns may be related to a person's lack of orientation to person, place, or time; language difficulties (inability to structure simple, complete sentences); or short term memory. The Hartford Institute for Geriatric Nursing recommends that a score of 23 or lower indicates cognitive impairment. (Accessed at www.harforddign.org). See appendix.
研究组 & 干预措施
Placebo for vitamin D3 and calcium carbonate
Placebo for daily vitamin D3 and calcium carbonate
干预措施: Calcium carbonate (Dietary Supplement)
vitamin D3 and calcium carbonate
Daily vitamin D3 2000 IU/day and calcium carbonate 1500mg/day supplementation
干预措施: Calcium carbonate (Dietary Supplement)
Placebo for vitamin D3 and calcium carbonate
Placebo for daily vitamin D3 and calcium carbonate
干预措施: Vitamin D3 (Dietary Supplement)
vitamin D3 and calcium carbonate
Daily vitamin D3 2000 IU/day and calcium carbonate 1500mg/day supplementation
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
all-type cancer (excluding non-melanoma skin cancers)
时间窗: 4 years
次要结局
- breast cancer(4 years)
- colorectal cancer(4 years)
- new osteoporotic fractures(4 years)
- frequency and severity of asthma symptoms in persons with asthma at baseline(4 years)
- frequency of falls(4 years)
- diagnosis of diabetes mellitus(4 years)
- frequency of colds and flu(4 years)
研究者
Joan Lappe
Professor of Nursing and Medicine
Creighton University