Breast Cancer Clinical Trial
— ViDAOfficial title:
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.
Status | Completed |
Enrollment | 218 |
Est. completion date | September 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 50 Years to 75 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
Country | Name | City | State |
---|---|---|---|
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Research Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | One Year | No | |
Secondary | Determine the effects of 12-months vitamin D vs. placebo on blood biomarkers (insulin,glucose,CRP) associated with increased breast cancer risk. | One Year | No | |
Secondary | 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 | No | |
Secondary | Test the effect of 12-month vitamin D supplementation on effects on quality of life (QOL) in women undergoing weight loss. | One Year | No | |
Secondary | Effect of Vitamin D supplementation on breast epithelial cell cytomorphology | 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). | One Year | No |
Secondary | Effect of Vitamin D on epithelial cell gene expression | 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 | One year | No |
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