Clinical Trial of Vitamin D3 to Reduce Cancer Risk in Postmenopausal Women

维生素 D3 降低绝经后妇女癌症风险的临床试验

基本信息

批准号：
7753215
负责人：
JOAN LAPPE
金额：
$ 86.64万
依托单位：
CREIGHTON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-01-01 至 2013-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7753215
关键词：
1,25 (OH) vitamin D 25-hydroxyvitamin D 9 year old Address Adherence Adverse event Age-Years Animals Bladder Breast Calcium Cardiovascular Diseases Cell Differentiation process Cells Cessation of life Chemopreventive Agent Cholecalciferol Clinical Trials Clinical Trials Design Cohort Studies Colon Colon Carcinoma Colonic Adenoma County Data Degenerative polyarthritis Diabetes Mellitus Dietary Intervention Dietary intake Dihydroxycholecalciferols Disease Double-Blind Method Enrollment Epidemiologic Studies Epidemiology Esophagus Foundations Fracture Future Genetic Markers Goals Health Health Policy Height Hypertension In Vitro Incidence Intake Intervention Intervention Studies Kidney Leukocytes Life Link Lung Malignant Neoplasms Malignant neoplasm of pancreas Mediating Medical Methods Mixed Function Oxygenases Multiple Myeloma Nebraska Nested Case-Control Study Non-Hodgkin&apos s Lymphoma Nurses Nutritional Outcome Outcome Study Ovary Pancreas Paper Participant Patient Self-Report Physical activity Placebos Population Postmenopause Prostate Publishing Radiation Randomized Randomized Clinical Trials Randomized Controlled Clinical Trials Receptor Activation Recording of previous events Rectum Reporting Research Risk Risk Factors Rural Sampling Science Serum Source Stimulus Stomach Strategic Planning Study of serum Sunlight Supplementation Testing Time Tissues Upper Respiratory Infections Uterus Visceral Visit Vitamin D Vitamin D Nutrition Vitamin D3 Receptor Vitamins Weight Woman angiogenesis animal data autocrine base calcium intake cancer diagnosis cancer prevention cancer risk cancer type chemical carcinogenesis cohort dimethylbenzanthracene falls follow-up leukemia/lymphoma malignant breast neoplasm men mortality population based prevent primary outcome randomized placebo controlled trial response social

项目摘要

DESCRIPTION (provided by applicant): An inverse correlation between cancer mortality rates and regional solar UV-B radiation exposure, a major source of vitamin D, has been found for cancers of the breast, colon, rectum, ovary; prostate, stomach, bladder, esophagus, kidney, lung, pancreas, and uterus, as well as non-Hodgkins lymphoma, and multiple myeloma. The anticancer effect of vitamin D is strongly supported by in vitro, animal, and epidemiological studies. Although a large body of evidence now links low vitamin D intake and low serum 25- hydroxyvitamin D (25OHD) to increased risk of various types of cancer, no reports were found of the effects of vitamin D status on all-cancer incidence. Furthermore, no randomized clinical trials have been reported that used a vitamin D intervention sufficient to raise serum 25OHD to optimum levels and that targeted a cancer outcome. A recent population-based study done by our group to determine the anti-fracture efficacy of calcium and vitamin D3 supplementation in healthy postmenopausal women demonstrated that vitamin D3 reduces all-cancer incidence. These findings need to be confirmed with a randomized controlled clinical trial designed with incidence of cancer as the primary outcome variable. In this application we propose to test whether increasing serum 25OHD to optimal levels, while maintaining adequate calcium intake, reduces the incidence of cancer in a population-based sample of postmenopausal women 60+ years of age. The Specific Aims are to: 1. Sample randomly the population of healthy independently-living postmenopausal women 60 years and older from 9 adjacent rural counties in Nebraska; 2. Enroll 2300 women into an intervention study, assign them randomly to 1 of 2 treatment groups: 1) vitamin D3 (2000 ID/d) and calcium (1200 mg/d), or 2) vitamin D3 placebo and calcium placebo, and to follow each subject for 4 years; 3. Collect and store white blood cells from every subject to test for genetic markers should the intervention be found effective in decreasing the incidence of cancer; 4. Determine the effect of supplementation with vitamin D3on incidence of all types of cancer combined; 5. Determine in a nested-case control study the association of serum 25OHD collected at randomization and at the end of year 1 of study with risk of cancer over 4 years. At each semiannual visit, the following will be assessed: medical and social history; adverse events; cancer diagnoses; and adherence to supplement/placebo. Annually, we will obtain height and weight and analyze serum 25OHD and1,25-dihydroxyvitamin D. At baseline and end of follow-up, we will assess dietary intake and physical activity. The proposed study addresses the goal of NCI's Strategic Plan to "eliminate the suffering and death due to cancer by 2015." It specifically addresses Strategic Objective 2, to "accelerate progress in cancer prevention." Positive findings from our proposed nutritional intervention study will result in an inexpensive, safe method of preventing cancer.

描述（由申请人提供）：发现乳腺癌，结肠癌，直肠，卵巢的癌症死亡率和区域太阳UV-B辐射暴露之间的逆相关性是维生素D的主要来源；前列腺，胃，膀胱，食道，肾脏，肺，胰腺和子宫以及非霍奇金斯淋巴瘤和多发性骨髓瘤。维生素D的抗癌作用得到了体外，动物和流行病学研究的强烈支持。尽管现在有大量证据将低维生素D摄入量和低血清25-羟基维生素D（25OHD）连接到各种癌症的风险增加，但没有发现任何有报道称维生素D状态对全癌发病率的影响。此外，尚无据报道，使用了足以将血清25OHD提高到最佳水平的维生素D干预措施的随机临床试验，并针对癌症结果。我们小组旨在确定健康后妇女中钙和维生素D3补充钙和维生素D3的抗冲突功效的最新基于人群的研究表明，维生素D3降低了全癌的发生率。这些发现需要通过以癌症为主要结果变量的随机对照临床试验来确认。在此应用中，我们建议测试将血清25OHD提高到最佳水平，同时保持足够的钙摄入量，从而降低了60岁以上的绝经后女性的基于人群的癌症的发生率。具体目的是：1。从内布拉斯加州的9个相邻乡村县60岁及以上的健康独立后的绝经后妇女进行样本样本； 2。将2300名妇女招募参加干预研究，将其随机分配给2个治疗组中的1个：1）维生素D3（2000 ID/D）和钙（1200 mg/d），或2）维生素D3安慰剂和安慰剂，并跟随每个受试者4年； 3.如果发现干预措施有效降低癌症的发生率，则收集和存储白细胞的遗传标记。 4。确定所有类型癌症的维生素D3ON发病率补充的影响； 5。确定在一项嵌套对照研究中，在4年内，在随机分组和研究第一年末收集的血清25OHD与患癌症的风险相关。在每年的每年一次访问中，将评估以下内容：医疗和社会历史；不利事件；癌症诊断；并遵守补充/安慰剂。每年，我们将获得身高和体重，并分析血清25OHD和1,25-二羟基羟基胺D.在基线和随访结束时，我们将评估饮食摄入和体育锻炼。拟议的研究旨在解决NCI战略计划的目标，即“消除到2015年癌症引起的痛苦和死亡。”它专门针对战略目标2，以“加速预防癌症的进展”。我们提出的营养干预研究中的积极发现将导致一种廉价，安全的预防癌症方法。