Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
218 participants
INTERVENTIONAL
2010-10-31
2012-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vitamin D
2000 IU per day of Vitamin D
Vitamin D
2000 IU per day of Vitamin D
Placebo
Placebo
1 Placebo per day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vitamin D
2000 IU per day of Vitamin D
Placebo
1 Placebo per day
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
50 Years
75 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fred Hutchinson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
FHCRC
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anne McTiernan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Mason C, de Dieu Tapsoba J, Duggan C, Wang CY, Korde L, McTiernan A. Repletion of vitamin D associated with deterioration of sleep quality among postmenopausal women. Prev Med. 2016 Dec;93:166-170. doi: 10.1016/j.ypmed.2016.09.035. Epub 2016 Sep 28.
Mason C, Tapsoba JD, Duggan C, Imayama I, Wang CY, Korde L, McTiernan A. Effects of Vitamin D3 Supplementation on Lean Mass, Muscle Strength, and Bone Mineral Density During Weight Loss: A Double-Blind Randomized Controlled Trial. J Am Geriatr Soc. 2016 Apr;64(4):769-78. doi: 10.1111/jgs.14049. Epub 2016 Apr 5.
Duggan C, de Dieu Tapsoba J, Mason C, Imayama I, Korde L, Wang CY, McTiernan A. Effect of Vitamin D3 Supplementation in Combination with Weight Loss on Inflammatory Biomarkers in Postmenopausal Women: A Randomized Controlled Trial. Cancer Prev Res (Phila). 2015 Jul;8(7):628-35. doi: 10.1158/1940-6207.CAPR-14-0449. Epub 2015 Apr 23.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IR 7297
Identifier Type: OTHER
Identifier Source: secondary_id
SAC110024
Identifier Type: -
Identifier Source: org_study_id