Vitamin D, Diet and Activity Study - Full Text View

Purpose

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.

Condition	Intervention
Breast Cancer Obesity Hypovitaminosis D	Dietary Supplement: Vitamin D Dietary Supplement: Placebo


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title:	Vitamin D, Weight Loss, and Breast Cancer Biomarkers

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer hereditary hypophosphatemic rickets

MedlinePlus related topics: Breast Cancer Cancer Vitamin D Weight Control

Drug Information available for: Vitamin D

Genetic and Rare Diseases Information Center resources: Rickets

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:

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. [ Time Frame: One Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine the effects of 12-months vitamin D vs. placebo on blood biomarkers (insulin,glucose,CRP) associated with increased breast cancer risk. [ Time Frame: One Year ] [ Designated as safety issue: No ]
Test 12-months vitamin D effects on muscle strength as measured by 1RM leg press and bench press in women undergoing weight loss. [ Time Frame: One Year ] [ Designated as safety issue: No ]
Test the effect of 12-month vitamin D supplementation on effects on quality of life (QOL) in women undergoing weight loss. [ Time Frame: One Year ] [ Designated as safety issue: No ]
Effect of Vitamin D supplementation on breast epithelial cell cytomorphology [ Time Frame: One Year ] [ Designated as safety issue: No ]
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).
Effect of Vitamin D on epithelial cell gene expression [ Time Frame: One year ] [ Designated as safety issue: No ]
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


Enrollment:	218
Study Start Date:	October 2010
Study Completion Date:	September 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Vitamin D 2000 IU per day of Vitamin D	Dietary Supplement: Vitamin D 2000 IU per day of Vitamin D Other Name: calciferol
Placebo Comparator: Placebo	Dietary Supplement: Placebo 1 Placebo per day Other Name: Sugar pill

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.

Eligibility


Ages Eligible for Study:	50 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240213

Locations


United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

Investigators


Principal Investigator:	Anne McTiernan, MD, PhD	Fred Hutchinson Cancer Research Center

More Information

No publications provided by Fred Hutchinson Cancer Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mason C, Xiao L, Imayama I, Duggan C, Wang CY, Korde L, McTiernan A. Vitamin D3 supplementation during weight loss: a double-blind randomized controlled trial. Am J Clin Nutr. 2014 May;99(5):1015-25. doi: 10.3945/ajcn.113.073734. Epub 2014 Mar 12. Erratum in: Am J Clin Nutr. 2014 Oct;100(4):1213.


Responsible Party:	Anne McTiernan, MD PhD, FHCRC
ClinicalTrials.gov Identifier:	NCT01240213 History of Changes
Other Study ID Numbers:	SAC110024, IR 7297
Study First Received:	November 9, 2010
Last Updated:	August 5, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:


Vitamin D lifestyle intervention postmenopausal women

Additional relevant MeSH terms:


Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Ergocalciferols Vitamin D	Vitamins Bone Density Conservation Agents Growth Substances Micronutrients Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 02, 2015

Vitamin D, Diet and Activity Study (ViDA)