Vitamin D, Diet and Activity Study

Completed · Not applicable · Has a placebo group

Conditions studied: Breast Cancer, Obesity, Hypovitaminosis D

In brief

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.

Key facts

Study ID

NCT01240213

Run by

Fred Hutchinson Cancer Center

People needed

218

Starts

2010-10-01

Expected to finish

2012-09-01

Last updated by the study team

2013-08-07

Who can join

Age: 50 and older, up to 75. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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