Vitamin D, Diet and Activity Study



Status:Archived
Conditions:Breast Cancer, Cancer, Obesity Weight Loss, Gastrointestinal
Therapuetic Areas:Endocrinology, Gastroenterology, Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:October 2010
End Date:September 2012

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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.


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.


We found this trial at
1
site
1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Seattle, WA
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