Vitamin D, Weight Loss, and Breast Cancer Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 2
- 主要终点
- Compare the effects of a 1-year one year Vitamin D supplementation vs placebo, on weight loss in postmenopausal women following a weight loss diet and exercise program.
研究概览
简要总结
Experimental and human data suggests that vitamin D could protect against breast cancer. Overweight/obese individuals are at increased risk of low vitamin D levels. Vitamin D may reduce production of fat tissue, thereby reducing weight gain, which would result in lower levels of adipose-derived hormones and other breast cancer risk factors.The purpose of this study is to test the effect of vitamin D supplementation on the response to a weight loss (diet + exercise) intervention and select breast cancer risk factors in overweight and obese postmenopausal women with low blood vitamin D levels.
详细描述
Objective: To test the incremental effect of vitamin D supplementation (2000 IU/day) in 228 overweight and obese postmenopausal women with low blood vitamin D levels on response to a weight loss (diet + exercise) intervention in a double-blind placebo-controlled clinical trial.
Primary Aim:
• Determine the effects of 12-months vitamin D supplementation vs. placebo on weight loss in women following a weight loss diet and exercise program.
Secondary Aims:
- Determine the effects of 12-months vitamin D vs. placebo on blood biomarkers associated with increased breast cancer risk (insulin, glucose, CRP).
- Test 12-months vitamin D effects on muscle strength as measured by 1RM leg press and bench press in women undergoing weight loss.
- Test the effect of 12-month vitamin D supplementation on effects on quality of life (QOL) in women undergoing weight loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 50-75 years
- •Postmenopausal (no periods for past 12 months)
- •Screening serum vitamin D (25(OH)D) between 10 and 32 ng/mL ("insufficient")
- •No menopausal HRT use of any type including vaginal X 6 months and willing to avoid use for study duration
- •BMI > 25.0 kg/m2 (> 23.0 for Asians)
- •Physically able to undertake a calorie reduction and exercise program
- •Able to come for clinic visits, classes, and measurements, fill out questionnaires and logs in English
- •Gives informed consent, agrees to be randomly assigned
排除标准
- •Currently using more that 400 IU vitamin D from supplemental sources
- •Screening vitamin D level < 10 ng/mL (will be referred to primary provider) or > 32 ng/mL (already sufficient)
- •Osteoporosis
- •Renal disease, history of kidney stones
- •Any contra-indications to taking vitamin D 2000 IU/day
- •Plans to leave the study area within the follow-up period
- •Plans to join another organized weight loss program or take appetite suppressant medication during the study period
- •History of bariatric surgery
- •Current use of medications likely to interfere with adherence to interventions or study outcomes
- •Current smoker
- •Personal history of invasive or in situ breast cancer
- •Personal history of invasive cancer other than breast: except for non- melanoma skin cancer which would be eligible
- •Diabetes mellitus
- •Abnormalities on screening physical that contraindicate participation
- •Severe congestive heart failure per NYHA criteria 3 & 4
- •Contraindications for entry into a research exercise program: recent (within 6 months) myocardial infarction, pulmonary edema, myocarditis, pericarditis, unstable angina, pulmonary embolism, deep vein thrombosis, uncontrolled hypertension (systolic > 200, diastolic > 100), orthostatic hypotension, moderate/severe aortic stenosis, uncontrolled arrythmia, uncontrolled congestive heart failure, left bundle branch block, history of cardiac arrest or stroke
- •Alcohol or drug abuse, significant mental illness (as assessed by study staff impression)
- •For the RPFNA/adipose tissue substudy: bilateral breast cancer, bilateral mastectomy, unable or unwilling to stop aspirin or NSAIDs for 1 week before and after the procedure, allergy to anesthetics or local anesthetics.
结局指标
主要结局
Compare the effects of a 1-year one year Vitamin D supplementation vs placebo, on weight loss in postmenopausal women following a weight loss diet and exercise program.
时间窗: One Year
次要结局
- Determine the effects of 12-months vitamin D vs. placebo on blood biomarkers (insulin,glucose,CRP) associated with increased breast cancer risk.(One Year)
- Test 12-months vitamin D effects on muscle strength as measured by 1RM leg press and bench press in women undergoing weight loss.(One Year)
- Test the effect of 12-month vitamin D supplementation on effects on quality of life (QOL) in women undergoing weight loss.(One Year)
- Effect of Vitamin D supplementation on breast epithelial cell cytomorphology(One Year)
- Effect of Vitamin D on epithelial cell gene expression(One year)