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
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.
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|