Vitamin D and Breast Cancer Biomarkers in Female Patients
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|ClinicalTrials.gov Identifier: NCT01224678|
Recruitment Status : Completed
First Posted : October 20, 2010
Results First Posted : June 25, 2018
Last Update Posted : June 25, 2018
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RATIONALE: Vitamin D may help prevent breast cancer.
PURPOSE: This randomized clinical trial is studying vitamin D and breast cancer biomarkers in female patients.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Dietary Supplement: vitamin D Other: placebo||Phase 3|
- To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women.
- To explore changes in the serum biomarker IGF1 in response to one year of vitamin D or placebo supplementation in premenopausal women.
- To explore changes in cellular proliferation (atypia and Ki67) in response to one year of vitamin D or placebo supplementation in premenopausal women.
- To explore correlations between change in breast cancer biomarkers (density, IGF1, atypia, and Ki67) with each other and with change in vitamin D levels.
- To compare methods of mammographic density analysis.
- To validate a recently developed sunlight questionnaire.
OUTLINE: This is a multicenter study. Patients are stratified according to baseline vitamin D (sufficient [≥ 30 ng/mL or ≥ 75 mmol/L] vs insufficient [< 30 ng/mL or < 75 mmol/L]) and institutional random periareolar fine-needle aspiration (RPFNA) status (performs RPFNA vs does not perform RPFNA). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral placebo once daily for 12 months.
- Arm II: Patients receive oral vitamin D (2000 IU) once daily for 12 months. Tissue and blood samples are collected at baseline and at 12 months for laboratory biomarker analysis. Patients also complete questionnaires at baseline and at 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Vitamin D and Breast Cancer Biomarkers|
|Actual Study Start Date :||October 2010|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Placebo Comparator: Placebo
Patients receive oral placebo once daily for 12 months.
Experimental: Vitamin D
Patients receive oral vitamin D (2000 IU) once daily for 12 months.
Dietary Supplement: vitamin D
- Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms [ Time Frame: 12 months ]To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women. The percent change in breast density will be reported here.
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|Ages Eligible for Study:||up to 55 Years (Child, Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Premenopausal women 55 years of age or younger with regular menstrual cycles (at least four cycles in the last six months). Women with fewer than 4 menses in the last 6 months or who have had a hysterectomy with ovaries intact will be considered premenopausal if FSH level < 20.
- Women with breast density ≥ 25% (scattered fibroglandular densities or greater) are eligible.
Patients who are currently receiving hormone replacement therapy (estrogen or progesterone); or are taking tamoxifen or raloxifene are not eligible. Women who have taken these medications must have stopped for at least 4 months prior to study entry.
Topical estrogen (eg, transdermal patches and vaginal estrogens) is allowed.
- Patients who are currently using hormonal contraception, should be taking it for at least 4 months prior to study entry.
Vitamin D Use
- Patients who are taking regular vitamin D supplementation (above 400 IUs daily) and refuse or are unable to stop use are not eligible. Women who agree to stop will need to do so for at least 6 months prior to registration.
- Patients may not start vitamin D supplementation after registration (regardless of results of vitamin D testing) but they may continue vitamin D if they are already taking 400 IUs daily or less and have been taking vitamin D for at least 6 months prior to baseline mammogram.
- Patients with a history of breast cancer (including DCIS) or ovarian cancer are not eligible.
- Patients with a history of breast implants or breast reduction are not eligible.
- Patients with two or more bone fractures in the past five years are not eligible.
- Patients with a diagnosis of osteoporosis with physician recommendation for treatment of low bone mass are not eligible.
- Patients known to have hyperparathyroid disease or other serious disturbances of calcium metabolism requiring intervention in the past 5 years are not eligible.
- Patients with a history of kidney stones (unless documented not to have been a calcium stone) are not eligible.
- Patients participating in a concurrent breast cancer chemoprevention trial are not eligible.
- Required initial laboratory values - Calcium < 10.5 mg/dL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224678
|Study Chair:||Marie E. Wood, MD||University of Vermont|
|Responsible Party:||Alliance for Clinical Trials in Oncology|
|Other Study ID Numbers:||
CDR0000687263 ( Registry Identifier: NCI Physician Data Query )
|First Posted:||October 20, 2010 Key Record Dates|
|Results First Posted:||June 25, 2018|
|Last Update Posted:||June 25, 2018|
|Last Verified:||June 2018|
Neoplasms by Site
Physiological Effects of Drugs
Bone Density Conservation Agents