Vitamin D, Diet and Activity Study (ViDA)
2013年8月5日 更新者：Fred Hutchinson Cancer Center
Vitamin D, Weight Loss, and Breast Cancer Biomarkers
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.
研究概览
详细说明
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.
Additional Aims:
- In a 50% subset of women, test the effect of 12-month vitamin D supplementation vs. placebo on breast epithelial cell cytomorphology (quantified by the Masood cytology index) obtained through random periareolar fine needle aspiration (RPFNA).
- Collect subcutaneous abdominal fat aspirations in the 50% subsample of women.
OUTLINE: This is a randomized study. Participants are stratified according to body mass index (< 30 vs ≥ 30) and RPFNA-consent. All participants will receive a 6-month weight loss intervention (prescribed weight loss goal of 10% of initial body weight) followed by 6 months' maintenance therapy.
Baseline, 6-, and 12-month measurements will include weight, BMI, waist and hip circumference, serum 25-hydroxyvitamin D, fasting blood samples, and questionnaires on details of diet especially items containing vitamin D, physical activity levels, sun exposure including clothing and sunscreen habits, dietary supplement and vitamin use, and medications.
研究类型
介入性
注册 (实际的)
218
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Washington
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Seattle、Washington、美国、98109
- Fred Hutchinson Cancer Research Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 至 75年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂
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1 Placebo per day
其他名称：
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有源比较器：Vitamin D
2000 IU per day of Vitamin D
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2000 IU per day of Vitamin D
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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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.
大体时间：One Year
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One Year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Determine the effects of 12-months vitamin D vs. placebo on blood biomarkers (insulin,glucose,CRP) associated with increased breast cancer risk.
大体时间：One Year
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One Year
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Test 12-months vitamin D effects on muscle strength as measured by 1RM leg press and bench press in women undergoing weight loss.
大体时间：One Year
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One Year
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Test the effect of 12-month vitamin D supplementation on effects on quality of life (QOL) in women undergoing weight loss.
大体时间：One Year
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One Year
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Effect of Vitamin D supplementation on breast epithelial cell cytomorphology
大体时间：One Year
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In a 50% subset of women, test the effect of 12-month vitamin D supplementation vs. placebo on breast epithelial cell cytomorphology (quantified by the Masood cytology index) obtained through random periareolar fine needle aspiration (RPFNA).
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One Year
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Effect of Vitamin D on epithelial cell gene expression
大体时间：One year
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In a 50% subset of women, test the effect of 12-month vitamin D supplementation vs. placebo on breast epithelial cell gene expression as measured by qRT-PCR.
The breast epithelial cells are collected by RPFNA
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One year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Anne McTiernan, MD, PhD、Fred Hutchinson Cancer Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Mason C, de Dieu Tapsoba J, Duggan C, Wang CY, Korde L, McTiernan A. Repletion of vitamin D associated with deterioration of sleep quality among postmenopausal women. Prev Med. 2016 Dec;93:166-170. doi: 10.1016/j.ypmed.2016.09.035. Epub 2016 Sep 28.
- Mason C, Tapsoba JD, Duggan C, Imayama I, Wang CY, Korde L, McTiernan A. Effects of Vitamin D3 Supplementation on Lean Mass, Muscle Strength, and Bone Mineral Density During Weight Loss: A Double-Blind Randomized Controlled Trial. J Am Geriatr Soc. 2016 Apr;64(4):769-78. doi: 10.1111/jgs.14049. Epub 2016 Apr 5.
- Duggan C, de Dieu Tapsoba J, Mason C, Imayama I, Korde L, Wang CY, McTiernan A. Effect of Vitamin D3 Supplementation in Combination with Weight Loss on Inflammatory Biomarkers in Postmenopausal Women: A Randomized Controlled Trial. Cancer Prev Res (Phila). 2015 Jul;8(7):628-35. doi: 10.1158/1940-6207.CAPR-14-0449. Epub 2015 Apr 23.
- Mason C, Xiao L, Imayama I, Duggan C, Wang CY, Korde L, McTiernan A. Vitamin D3 supplementation during weight loss: a double-blind randomized controlled trial. Am J Clin Nutr. 2014 May;99(5):1015-25. doi: 10.3945/ajcn.113.073734. Epub 2014 Mar 12. Erratum In: Am J Clin Nutr. 2014 Oct;100(4):1213.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年10月1日
初级完成 (实际的)
2012年8月1日
研究完成 (实际的)
2012年9月1日
研究注册日期
首次提交
2010年11月9日
首先提交符合 QC 标准的
2010年11月10日
首次发布 (估计)
2010年11月15日
研究记录更新
最后更新发布 (估计)
2013年8月7日
上次提交的符合 QC 标准的更新
2013年8月5日
最后验证
2013年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.