Status:
COMPLETED
Vitamin D, Diet and Activity Study
Lead Sponsor:
Fred Hutchinson Cancer Center
Conditions:
Breast Cancer
Obesity
Eligibility:
FEMALE
50-75 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT01240213
Start Date
October 1 2010
End Date
September 1 2012
Last Update
August 7 2013
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109