Spots Global Cancer Trial Database for Vitamin D, Diet and Activity Study

Study Description

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 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.

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 + 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.

Keywords

Eligibility

Minimum Age: 50 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

Contact Details

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