Study of Vitamin D for Premenopausal Women at High Risk for Breast Cancer
NCT ID: NCT00976339
Last Updated: 2017-09-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2007-09-30
2013-12-31
Brief Summary
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Detailed Description
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Vitamin D is a fat-soluble vitamin which is produced in the body and may come from food sources. Epidemiologic studies suggest that vitamin D may influence breast cancer development, which has resulted in increased interest in the use of vitamin D for the treatment and prevention of breast cancer. Numerous experimental studies have shown that vitamin D compounds have anti-carcinogenic properties against breast cancer. Given the epidemiologic data and the extensive preclinical evidence of the anti-tumor effects of vitamin D, it is therefore reasonable to test the biological effects of high-dose vitamin D in early phase clinical trials. The investigators hypothesize that vitamin D3, cholecalciferol, will modulate biomarkers of breast cancer risk.
The relationship between vitamin D status and mammographic density (MD), a strong predictor of breast cancer risk, remains unclear \[8\]. MD refers to the relative proportions of radiolucent fat and radiodense epithelial and stromal tissue and may serve as a useful intermediate biomarker for breast cancer risk assessment in investigations of potential chemopreventive agents. Cross-sectional studies evaluating the association between vitamin D intake and MD observed an inverse association among premenopausal women, particularly with high serum IGF-1 and low serum IGF binding protein-3 (IGFBP-3). However, there is limited data on the biologic effects of vitamin D supplementation for breast cancer prevention in human intervention trials.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Cholecalciferol 20,000 IU
Participants will receive Cholecalciferol 20,000 IU (2 capsules) weekly for one year.
Cholecalciferol
Cholecalciferol is a vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body. Cholecalciferol is used to treat or prevent many conditions caused by a lack of vitamin D.
Cholecalciferol will be available in gel capsule form at 10,000 IU (0.25 mg cholecalciferol) each.
Cholecalciferol 30,000 IU
Participants will receive Cholecalciferol 30,000 IU (3 capsules) weekly for one year.
Cholecalciferol
Cholecalciferol is a vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body. Cholecalciferol is used to treat or prevent many conditions caused by a lack of vitamin D.
Cholecalciferol will be available in gel capsule form at 10,000 IU (0.25 mg cholecalciferol) each.
Interventions
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Cholecalciferol
Cholecalciferol is a vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body. Cholecalciferol is used to treat or prevent many conditions caused by a lack of vitamin D.
Cholecalciferol will be available in gel capsule form at 10,000 IU (0.25 mg cholecalciferol) each.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 21 years or older.
* Premenopausal defined as \< 6 months since the last menstrual period, no prior bilateral oophorectomy, not on estrogen replacement, and serum Follicle-stimulating hormone (FSH) values consistent with institutional normal values for the premenopausal state.
* Normal breast exam and mammogram (BIRADS score of 1 or 2).
* Baseline mammographic density ≥25% as assessed qualitatively by the mammographer (25-50% = "scattered fibroglandular densities"; \>50-75% = "heterogeneously dense breasts"; \>75% = "extremely dense breasts").
* Baseline serum 25-hydroxyvitamin D \<32 ng/ml.
* Prior tamoxifen use is allowed provided treatment is discontinued at least 28 days prior to enrollment.
* Willingness to allow submission of core needle breast biopsy for pathology review and collection of blood for biomarker analysis and banking.
* At least one breast available for imaging and biopsy.
* Willingness to not take calcium or vitamin D supplements during the one year intervention, due to the potential risk of hypercalcemia/hypercalciuria with high dose vitamin D. Premenopausal women who need to take calcium supplementation for any medical condition will be excluded from the study. Dietary restrictions on calcium intake may be imposed if the subject is found to have borderline high serum or urine levels of calcium during the study intervention and a list of dietary sources of calcium will be provided.
* Normal serum calcium.
* No history of kidney stones.
* Adequate renal and hepatic function: serum creatinine, bilirubin, aspartate aminotransferase (AST), alanine transaminase (ALT) and alkaline phosphatase \< 2.0 x the institutional upper limit of normal (IULN).
* No hypersensitivity reactions to vitamin D.
* Performance status of 0 or 1.
* Not pregnant or nursing.
* Agree to use effective contraception, hormone-based oral contraceptives allowed but switching birth control methods is discouraged while on-study.
* No significant medical or psychiatric condition that would preclude study completion.
21 Years
FEMALE
Yes
Sponsors
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Prevent Cancer Foundation
OTHER
Katherine D. Crew
OTHER
Responsible Party
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Katherine D. Crew
Florence Irving Assistant Professor of Medicine and Assistant Professor of Epidemiology
Principal Investigators
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Katherine Crew, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Columbia University Medical Center Herbert Irving Cancer Center
New York, New York, United States
Countries
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References
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Vieth R, Chan PC, MacFarlane GD. Efficacy and safety of vitamin D3 intake exceeding the lowest observed adverse effect level. Am J Clin Nutr. 2001 Feb;73(2):288-94. doi: 10.1093/ajcn/73.2.288.
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Chen WY, Bertone-Johnson ER, Hunter DJ, Willett WC, Hankinson SE. Associations between polymorphisms in the vitamin D receptor and breast cancer risk. Cancer Epidemiol Biomarkers Prev. 2005 Oct;14(10):2335-9. doi: 10.1158/1055-9965.EPI-05-0283.
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Lowe L, Hansen CM, Senaratne S, Colston KW. Mechanisms implicated in the growth regulatory effects of vitamin D compounds in breast cancer cells. Recent Results Cancer Res. 2003;164:99-110. doi: 10.1007/978-3-642-55580-0_6.
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Other Identifiers
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AAAC3089
Identifier Type: -
Identifier Source: org_study_id