- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01224678
Vitamin D and Breast Cancer Biomarkers in Female Patients
Vitamin D and Breast Cancer Biomarkers
RATIONALE: Vitamin D may help prevent breast cancer.
PURPOSE: This randomized clinical trial is studying vitamin D and breast cancer biomarkers in female patients.
연구 개요
상세 설명
OBJECTIVES:
Primary
- To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women.
Secondary
- 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.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Alabama
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Anniston, Alabama, 미국, 36207
- Regional Medical Center
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California
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Martinez, California, 미국, 94553-3156
- Contra Costa Regional Medical Center
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Mountain View, California, 미국, 94040
- El Camino Hospital Cancer Center
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Mountain View, California, 미국, 94040
- Camino Medical Group - Treatment Center
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Oakland, California, 미국, 94609
- Larry G Strieff MD Medical Corporation
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Oakland, California, 미국, 94609
- CCOP - Bay Area Tumor Institute
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Oakland, California, 미국, 94609
- Bay Area Breast Surgeons, Incorporated
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Oakland, California, 미국, 94609
- Tom K Lee, Incorporated
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Palo Alto, California, 미국, 94301
- Palo Alto Medical Foundation
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Pismo Beach, California, 미국, 93449
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San Pablo, California, 미국, 94806
- Doctors Medical Center - San Pablo Campus
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Connecticut
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Greenwich, Connecticut, 미국, 06830
- Bendheim Cancer Center at Greenwich Hospital
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Florida
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Fort Lauderdale, Florida, 미국, 33308
- Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
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Jupiter, Florida, 미국, 33458
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
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Miami Beach, Florida, 미국, 33140
- CCOP - Mount Sinai Medical Center
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Orlando, Florida, 미국, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Illinois
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Bloomington, Illinois, 미국, 61701
- Illinois CancerCare - Bloomington
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Bloomington, Illinois, 미국, 61701
- St. Joseph Medical Center
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Canton, Illinois, 미국, 61520
- Illinois CancerCare - Canton
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Chicago, Illinois, 미국, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, 미국, 60640
- Louis A. Weiss Memorial Hospital
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Eureka, Illinois, 미국, 61530
- Illinois CancerCare - Eureka
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Eureka, Illinois, 미국, 61530
- Eureka Community Hospital
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Galesburg, Illinois, 미국, 61401
- Galesburg Clinic, PC
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Macomb, Illinois, 미국, 61455
- Illinois CancerCare - Macomb
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Macomb, Illinois, 미국, 61455
- Mcdonough District Hospital
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Normal, Illinois, 미국, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, 미국, 61761
- Community Cancer Center
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Normal, Illinois, 미국, 61761
- Illinois CancerCare - Community Cancer Center
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Ottawa, Illinois, 미국, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, 미국, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, 미국, 61554
- Cancer Treatment Center at Pekin Hospital
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Pekin, Illinois, 미국, 61603
- Illinois CancerCare - Pekin
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Peoria, Illinois, 미국, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, 미국, 61614
- Proctor Hospital
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Peoria, Illinois, 미국, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, 미국, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, 미국, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, 미국, 61354
- Illinois CancerCare - Peru
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Peru, Illinois, 미국, 61354
- Illinois Valley Community Hospital
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Spring Valley, Illinois, 미국, 61362
- Illinois CancerCare - Spring Valley
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Indiana
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Elkhart, Indiana, 미국, 46515
- Elkhart General Hospital
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Elkhart, Indiana, 미국, 46514-2098
- Elkhart Clinic, LLC
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Elkhart, Indiana, 미국, 46514
- Michiana Hematology-Oncology, PC - Elkhart
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Kokomo, Indiana, 미국, 46904
- Howard Community Hospital
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La Porte, Indiana, 미국, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Mishawaka, Indiana, 미국, 46545-1470
- Michiana Hematology-Oncology, PC - South Bend
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Mishawaka, Indiana, 미국, 46545-1470
- Saint Joseph Regional Medical Center
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Plymouth, Indiana, 미국, 46563
- Michiana Hematology Oncology PC - Plymouth
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South Bend, Indiana, 미국, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, 미국, 46601
- CCOP - Northern Indiana CR Consortium
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Westville, Indiana, 미국, 46391
- Michiana Hematology Oncology PC - La Porte
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Maryland
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Bethesda, Maryland, 미국, 20889-5600
- National Naval Medical Center
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
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Lowell, Massachusetts, 미국, 01854
- Lowell General Hospital
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Newton, Massachusetts, 미국, 02462
- Newton-Wellesley Hospital
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South Weymouth, Massachusetts, 미국, 02190
- Dana-Farber/Brigham and Women's Cancer Center at South Shore
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Michigan
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Battle Creek, Michigan, 미국, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, 미국, 49307
- Mecosta County Medical Center
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Grand Rapids, Michigan, 미국, 49503
- Butterworth Hospital at Spectrum Health
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Grand Rapids, Michigan, 미국, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, 미국, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Muskegon, Michigan, 미국, 49444
- Mercy General Health Partners
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Saint Joseph, Michigan, 미국, 49085
- Lakeside Cancer Specialists, PLLC
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Saint Joseph, Michigan, 미국, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Traverse City, Michigan, 미국, 49684
- Munson Medical Center
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic Cancer Center
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Missouri
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Chesterfield, Missouri, 미국, 63017
- Saint Luke's Hospital
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Columbia, Missouri, 미국, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Nebraska
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Omaha, Nebraska, 미국, 68114
- Methodist Estabrook Cancer Center
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New Hampshire
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Concord, New Hampshire, 미국, 03301
- New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
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Hooksett, New Hampshire, 미국, 03106
- New Hampshire Oncology - Hematology, PA - Hooksett
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Laconia, New Hampshire, 미국, 03246
- Lakes Region General Hospital
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Lebanon, New Hampshire, 미국, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New York
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Buffalo, New York, 미국, 14263-0001
- Roswell Park Cancer Institute
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East Syracuse, New York, 미국, 13057
- CCOP - Hematology-Oncology Associates of Central New York
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Elmhurst, New York, 미국, 11373
- Elmhurst Hospital Center
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Glens Falls, New York, 미국, 12801
- Charles R. Wood Cancer Center at Glens Falls Hospital
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Jamaica, New York, 미국, 11432
- Queens Cancer Center of Queens Hospital
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New York, New York, 미국, 10029
- Mount Sinai Medical Center
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Syracuse, New York, 미국, 13210
- SUNY Upstate Medical University Hospital
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Utica, New York, 미국, 13502
- Faxton Regional Cancer Center
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North Carolina
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Charlotte, North Carolina, 미국, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
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Durham, North Carolina, 미국, 27710
- Duke Cancer Institute
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Goldsboro, North Carolina, 미국, 27534
- Wayne Memorial Hospital, Incorporated
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Raleigh, North Carolina, 미국, 27614
- Rex Cancer Center of Wakefield
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Raleigh, North Carolina, 미국, 27607
- Rex Cancer Center at Rex Hospital
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Wilmington, North Carolina, 미국, 28401
- Zimmer Cancer Center at New Hanover Regional Medical Center
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Winston-Salem, North Carolina, 미국, 27103
- Forsyth Regional Cancer Center at Forsyth Medical Center
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Ohio
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Columbus, Ohio, 미국, 43210-1240
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
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Lima, Ohio, 미국, 45801
- St. Rita's Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73104
- Oklahoma University Cancer Institute
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Oklahoma City, Oklahoma, 미국, 73120
- Cancer Care Associates - Mercy Campus
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South Carolina
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Greenville, South Carolina, 미국, 29615
- CCOP - Greenville
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Greenville, South Carolina, 미국, 29605
- Greenville Hospital Cancer Center
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Greenville, South Carolina, 미국, 29605
- Cancer Centers of the Carolinas - Faris Road
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Seneca, South Carolina, 미국, 29672
- Cancer Centers of the Carolinas - Seneca
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Spartanburg, South Carolina, 미국, 29307
- Cancer Centers of the Carolinas - Spartanburg
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Tennessee
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Kingsport, Tennessee, 미국, 37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
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Texas
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Houston, Texas, 미국, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Laredo, Texas, 미국, 78045
- Doctor's Hospital of Laredo
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Vermont
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Berlin, Vermont, 미국, 05602
- Mountainview Medical
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Burlington, Vermont, 미국, 05401
- Fletcher Allen Health Care - University Health Center Campus
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
- 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.
Prior Treatment
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
위약 비교기: Placebo
Patients receive oral placebo once daily for 12 months.
|
구두로 주어진
|
실험적: Vitamin D
Patients receive oral vitamin D (2000 IU) once daily for 12 months.
|
Given orally
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms
기간: 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.
|
12 months
|
공동 작업자 및 조사자
수사관
- 연구 의자: Marie E. Wood, MD, University of Vermont
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
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AJU Pharm Co., Ltd.OM Pharma SA모병
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University Hospital, Strasbourg, France모집하지 않고 적극적으로