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Title: Women's Health Initiative      
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description:
The Women's Health Initiative (WHI) is a long-term national health study that has focused on strategies for preventing heart disease, breast and colorectal cancer, and osteoporotic fractures in postmenopausal women. The original WHI study included 161,808 postmenopausal women enrolled between 1993 and 1998. The Fred Hutchinson Cancer Research Center in Seattle, WA serves as the WHI Clinical Coordinating Center for data collection, management, and analysis of the WHI. The WHI has two major parts: a partial factorial randomized Clinical Trial (CT) and an Observational Study (OS); both were conducted at 40 Clinical Centers nationwide. The CT enrolled 68,132 postmenopausal women between the ages of 50-79 into trials testing three prevention strategies. If eligible, women could choose to enroll in one, two, or all three of the trial components. The components are: Hormone Therapy Trials (HT): This double-blind component examined the effects of combined hormones or estrogen alone on the prevention of coronary heart disease and osteoporotic fractures, and associated risk for breast cancer. Women participating in this component with an intact uterus were randomized to estrogen plus progestin (conjugated equine estrogens [CEE], 0.625 mg/d plus medroxyprogesterone acetate [MPA] 2.5 mg/d] or a matching placebo. Women with prior hysterectomy were randomized to CEE or placebo. Both trials were stopped early, in July 2002 and March 2004, respectively, based on adverse effects. All HT participants continued to be followed without intervention until close-out. Dietary Modification Trial (DM): The Dietary Modification component evaluated the effect of a low-fat and high fruit, vegetable and grain diet on the prevention of breast and colorectal cancers and coronary heart disease. Study participants were randomized to either their usual eating pattern or a low-fat dietary pattern. Calcium/Vitamin D Trial (CaD): This double-blind component began 1 to 2 years after a woman joined one or both of the other clinical trial components. It evaluated the effect of calcium and vitamin D supplementation on the prevention of osteoporotic fractures and colorectal cancer. Women in this component were randomized to calcium (1000 mg/d) and vitamin D (400 IU/d) supplements or a matching placebo. The Observational Study (OS) examines the relationship between lifestyle, environmental, medical and molecular risk factors and specific measures of health or disease outcomes. This component involves tracking the medical history and health habits of 93,676 women not participating in the CT. Recruitment for the observational study was completed in 1998 and participants were followed annually for 8 to 12 years. The original protocol allowed for follow-up until March 2005, after which participants were invited to enroll in the first WHI Extension Study for follow-up through 2010. Participants were invited again to participate in the second WHI Extension Study with continued follow up from 2010 to 2015. As of March 31, 2011 there were 93,122 women enrolled in the second extension. As part of the second Extension, 80+ year old women were asked to consent to an In Person Visit at their homes during which additional blood samples were collected and various measurements were taken (such as blood pressure, height, weight, waist circumference, grip strength, etc). The WHI Cohort is utilized in the following dbGaP substudies. To view genotypes, analysis, expression data, other molecular data, and derived variables collected in these substudies, please click on the following substudies below or in the "Substudies" box located on the right hand side of this top-level study page phs000200 WHI Cohort. phs000386 WHI SHARe phs000281 GO-ESP WHISP phs000315 WHI GARNET phs000503 WHISE phs000227 PAGE WHI phs000675 WHIMS+ phs000746 WHI Harmonized and Imputed GWAS
Identifier:
phs000200.v10.p3
accesstypes:
download
enclave
landingpage: http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000200.v10.p3
authentication: simpleLogin
none
authorization:
none
duaIndividual
name:
Women's Health
Adrenal Gland Neoplasms
Angina Pectoris
Angioplasty, Transluminal, Percutaneous Coronary
Anus Neoplasms
Appendiceal Neoplasms
Arthritis, Rheumatoid
Biliary Tract Neoplasms
Bone Neoplasms
Brain Neoplasms
Breast Neoplasms
Carotid Artery Diseases
Cataract
Central Nervous System Cysts
Colorectal Neoplasms
Coronary Artery Bypass
Coronary Disease
Diabetes Mellitus
Endocrine Gland Neoplasms
Esophageal Neoplasms
Eye Neoplasms
Fractures, Bone
Gallbladder Diseases
Glaucoma
Heart Failure
Hip Fractures
Hodgkin Disease
Humeral Fractures
Hypertension
Hysterectomy
Intestinal Polyps
Kidney Calculi
Kidney Neoplasms
Laryngeal Neoplasms
Leukemia
Liver Neoplasms
Lung Neoplasms
Lupus Erythematosus, Cutaneous
Lymph Nodes
Lymphoma, Non-Hodgkin
Melanoma
Meningeal Neoplasms
Mouth Neoplasms
Multiple Myeloma
Myocardial Infarction
Neoplasms, Connective and Soft Tissue
Osteoporosis, Postmenopausal
Palatal Neoplasms
Pancreatic Neoplasms
Paranasal Sinus Neoplasms
Parotid Neoplasms
Peripheral Nervous System Neoplasms
Peripheral Vascular Diseases
Radius Fractures
Respiratory Tract Neoplasms
Salivary Gland Neoplasms
Spinal Cord Neoplasms
Spinal Fractures
Stomach Neoplasms
Stroke
Thyroid Neoplasms
Tibial Fractures
Tongue Neoplasms
Ulna Fractures
Ureteral Neoplasms
Urethral Neoplasms
Urinary Bladder Neoplasms
Urogenital Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
affiliations:
Women's Health Initiative, National Institutes of Health, Bethesda, MD, USA
name:
Jacques Rossouw, WHI Lead Project Officer, Branch Chief
roles:
Study Leadership
affiliations:
Women's Health Initiative, National Institutes of Health, Bethesda, MD, USA
name:
Shari Ludlam, Scientific Program Specialist
roles:
Study Leadership
affiliations:
Women's Health Initiative, National Institutes of Health, Bethesda, MD, USA
name:
Peggy Mills, Contracts Team Leader
roles:
Study Leadership
affiliations:
DCVS, National Institutes of Health, Bethesda, MD, USA
name:
Jeffrey Williams, Contract Specialist
roles:
Study Leadership
affiliations:
Fred Hutchinson Cancer Research Center, Seattle, WA, USA
name:
Garnet Anderson, Principal Investigator
roles:
Coordinating Center
affiliations:
Fred Hutchinson Cancer Research Center, Seattle, WA, USA
name:
Ross Prentice, Co-Principal Investigator
roles:
Coordinating Center
affiliations:
Fred Hutchinson Cancer Research Center, Seattle, WA, USA
name:
Andrea LaCroix, Investigator
roles:
Coordinating Center
affiliations:
Fred Hutchinson Cancer Research Center, Seattle, WA, USA
name:
Charles Kooperberg, Investigator
roles:
Coordinating Center
affiliations:
Fred Hutchinson Cancer Research Center, Seattle, WA, USA
name:
Susan Anderson, Coordinating Center Manager
roles:
Coordinating Center
affiliations:
Fred Hutchinson Cancer Research Center, Seattle, WA, USA
name:
Bernedine Lund, Technical Director
roles:
Coordinating Center
affiliations:
Fred Hutchinson Cancer Research Center, Seattle, WA, USA
name:
Garnet Anderson
roles:
Principal Investigators
affiliations:
University of Washington, Seattle, WA, USA
name:
Shirley Beresford
roles:
Principal Investigators
affiliations:
University of Nevada, Reno, NV, USA
name:
Robert Brunner
roles:
Principal Investigators
affiliations:
University of Texas Health Science Center, San Antonio, TX, USA
name:
Robert Brzyski
roles:
Principal Investigators
affiliations:
Kaiser Permanente - Division of Research, Oakland, CA, USA
name:
Bette Caan
roles:
Principal Investigators
affiliations:
University of California - Torrance, Torrance, CA, USA
name:
Rowan Chlebowski
roles:
Principal Investigators
affiliations:
University of Hawaii at Manoa, Honolulu, HI, USA
name:
J. David Curb
roles:
Principal Investigators
affiliations:
Memorial Hospital of Rhode Island, Pawtucket, RI, USA
name:
Charles Eaton
roles:
Principal Investigators
affiliations:
University of North Carolina - Chapel Hill, Chapel Hill, NC, USA
name:
Gerardo Heiss
roles:
Principal Investigators
affiliations:
Medstar Research Center, Hyattsville, MD, USA
name:
Barbara Howard
roles:
Principal Investigators
affiliations:
University of California - Irvine, Irvine, CA, USA
name:
F. Allan Hubbell
roles:
Principal Investigators
affiliations:
Ohio State University, Columbus, OH, USA
name:
Rebecca Jackson
roles:
Principal Investigators
affiliations:
University of Tennessee Health Science Center, Memphis, TN, USA
name:
Karen Johnson
roles:
Principal Investigators
affiliations:
Fred Hutchinson Cancer Research Center, Seattle, WA, USA
name:
Charles Kooperberg
roles:
Principal Investigators
affiliations:
Medical College of Wisconsin, Milwaukee, WI, USA
name:
Jane Morley Kotchen
roles:
Principal Investigators
affiliations:
University of Pittsburgh, Pittsburgh, PA, USA
name:
Lewis Kuller
roles:
Principal Investigators
affiliations:
Fred Hutchinson Cancer Research Center, Seattle, WA, USA
name:
Andrea LaCroix
roles:
Principal Investigators
affiliations:
SUNY at Stony Brook, Stony Brook, NY, USA
name:
Dorothy Lane
roles:
Principal Investigators
affiliations:
University of Medicine and Dentistry of New Jersey, Newark, NJ, USA
name:
Norman Lasser
roles:
Principal Investigators
affiliations:
Oregon Health and Science University, Portland, OR, USA
name:
Erin LeBlanc
roles:
Principal Investigators
affiliations:
Univeristy of Alabama at Birmingham, Birmingham, AL, USA
name:
Cora (Beth) Lewis
roles:
Principal Investigators
affiliations:
University of Florida, Gainesville, FL, USA
name:
Marian Limacher
roles:
Principal Investigators
affiliations:
Brigham and Women's Hospital, Boston, MA, USA
name:
JoAnn Manson
roles:
Principal Investigators
affiliations:
HealthPartners Research Foundation, Bloomington, MN, USA
name:
Karen Margolis
roles:
Principal Investigators
affiliations:
George Washington University, Washington, DC, USA
name:
Lisa Martin
roles:
Principal Investigators
affiliations:
University of California - Los Angeles, Los Angeles, CA, USA
name:
Lauren Nathan
roles:
Principal Investigators
affiliations:
University of Massachusetts Medical School, Worcester, MA, USA
name:
Judith Ockene
roles:
Principal Investigators
affiliations:
University of Miami, Miami, FL, USA
name:
Mary Jo O'Sullivan
roles:
Principal Investigators
affiliations:
Emory University, Decatur, GA, USA
name:
Larry Phillips
roles:
Principal Investigators
affiliations:
Rush University Medical Center, Chicago, IL, USA
name:
Lynda Powell
roles:
Principal Investigators
affiliations:
Fred Hutchinson Cancer Research Center, Seattle, WA, USA
name:
Ross Prentice
roles:
Principal Investigators
affiliations:
Baylor College of Medicine, Houston, TX, USA
name:
Haleh Sangi-Haghpeykar
roles:
Principal Investigators
affiliations:
University of California at Davis, Sacramento, CA, USA
name:
John Robbins
roles:
Principal Investigators
affiliations:
University of Wisonsin, Madison, WI, USA
name:
Gloria Sarto
roles:
Principal Investigators
affiliations:
Wake Forest University Health Sciences, Winston Salem, NC, USA
name:
Sally Shumaker
roles:
Principal Investigators
affiliations:
Karmanos Cancer Institute, Detroit, MI, USA
name:
Michael Simon
roles:
Principal Investigators
affiliations:
Stanford University School of Medicine, Stanford, CA, USA
name:
Marcia Stefanick
roles:
Principal Investigators
affiliations:
University of Cincinnati College of Medicine, Cincinnati, OH, USA
name:
Michael Thomas
roles:
Principal Investigators
affiliations:
University of Arizona - Tucson, Tucson, AZ, USA
name:
Cynthia Thomson
roles:
Principal Investigators
affiliations:
Northwestern University, Chicago, IL, USA
name:
Linda Van Horn
roles:
Principal Investigators
affiliations:
Wake Forest Univeristy Health Sciences, Winston Salem, NC, USA
name:
Mara Vitolins
roles:
Principal Investigators
affiliations:
University of Buffalo, Buffalo, NY, USA
name:
Jean Wactawski-Wende
roles:
Principal Investigators
affiliations:
University of Iowa, Iowa City, IA, USA
name:
Jennifer Robinson
roles:
Principal Investigators
affiliations:
Albert Einstein College of Medicine, Bronx, NY, USA
name:
Sylvia Wassertheil-Smoller
roles:
Principal Investigators
affiliations:
National Heart, Lung, and Blood Institute, National Instiutes of Health, Bethesda, MD, USA
name:
N01WH22110
roles:
Funding Source
affiliations:
National Heart, Lung, and Blood Institute, National Instiutes of Health, Bethesda, MD, USA
name:
N01WH24152
roles:
Funding Source
affiliations:
National Heart, Lung, and Blood Institute, National Instiutes of Health, Bethesda, MD, USA
name:
N01WH32100-2
roles:
Funding Source
affiliations:
National Heart, Lung, and Blood Institute, National Instiutes of Health, Bethesda, MD, USA
name:
N01WH32105-6
roles:
Funding Source
affiliations:
National Heart, Lung, and Blood Institute, National Instiutes of Health, Bethesda, MD, USA
name:
N01WH32108-9
roles:
Funding Source
affiliations:
National Heart, Lung, and Blood Institute, National Instiutes of Health, Bethesda, MD, USA
name:
N01WH32111-13
roles:
Funding Source
affiliations:
National Heart, Lung, and Blood Institute, National Instiutes of Health, Bethesda, MD, USA
name:
N01WH32115
roles:
Funding Source
affiliations:
National Heart, Lung, and Blood Institute, National Instiutes of Health, Bethesda, MD, USA
name:
N01WH32118-32119
roles:
Funding Source
affiliations:
National Heart, Lung, and Blood Institute, National Instiutes of Health, Bethesda, MD, USA
name:
N01WH32122
roles:
Funding Source
affiliations:
National Heart, Lung, and Blood Institute, National Instiutes of Health, Bethesda, MD, USA
name:
N01WH42107-26
roles:
Funding Source
affiliations:
National Heart, Lung, and Blood Institute, National Instiutes of Health, Bethesda, MD, USA
name:
N01WH42129-32
roles:
Funding Source
affiliations:
National Heart, Lung, and Blood Institute, National Instiutes of Health, Bethesda, MD, USA
name:
N01WH44221
roles:
Funding Source
performedBy:
TitleNameInstitute Principal InvestigatorsGarnet AndersonFred Hutchinson Cancer Research Center, Seattle, WA, USA Principal InvestigatorsShirley BeresfordUniversity of Washington, Seattle, WA, USA Principal InvestigatorsRobert BrunnerUniversity of Nevada, Reno, NV, USA Principal InvestigatorsRobert BrzyskiUniversity of Texas Health Science Center, San Antonio, TX, USA Principal InvestigatorsBette CaanKaiser Permanente - Division of Research, Oakland, CA, USA
downloadURL: https://dbgap.ncbi.nlm.nih.gov/aa/wga.cgi?page=DUC&view_pdf&stacc=phs000200.v10.p3
Identifier:
phs000200.v10.p3_policy
name:
Data Use Certificate
Identifier:
0
name:
Subjects did not participate in the study, did not complete a consent document and are included only for the pedigree structure and/or genotype controls, such as HapMap subjects
Identifier:
1
name:
Health/Medical/Biomedical (IRB)
Identifier:
2
name:
Health/Medical/Biomedical (IRB, NPU)
schedulesActivity:
October 1992 - Clinical Coordinating Center operations begin March 1993 - 16 Clinical Centers selected September 1993 - Recruitment of participants for 2 Hormone Therapy Trials (HT) trials and the Dietary Modification Trial (DM) begins September 1994 - 24 additional Clinical Centers selected; Recruitment of participants for the Observational Study (OS) begins June 1995 - CaD randomization begins August 1998 - Randomization of participants for the DM ends October 1998 - Randomization of participants for the HT ends December 1998 - Recruitment of participants for the OS ends September 2000 - Randomization of participants for the CaD ends July 2002 - Estrogen plus Progestin HT was stopped early and main results published March 2004 - Estrogen-Alone HT was stopped early April 2004 - Main results of Estrogen-Alone HT published; Closeout of OS begins October 2004 - Closeout of clinical trials (HT, DM, and CaD) begins March 2005 - Study close-out ends April 2005 - Extension study begins September 2005 - Final WHI outcomes obtained and WHI database closed February 2006 - Main results of DM and CaD published September 2010 - Extension 1 study closed October 2010 - Extension 2 study begins October 2011 - In Person Visits scheduled to begin December 2012 - In Person Visits scheduled to be complete September 2015 - Extension 2 study scheduled to close
alternateIdentifiers:
yes
selectionCriteria:

All women enrolled in the WHI were between 50 and 79 years old and were postmenopausal at the time of enrollment. In addition, eligibility criteria for the clinical trial (CT) and observational study (OS) included ability and willingness to provide written informed consent and an intention to reside in the area for at least 3 years after enrollment. Component specific exclusion criteria are listed in Table 1 of the Baseline Monograph paper (available at http://www.whiscience.org/about/baseline/baseline_Recruitment.pdf).

dateReleased:
04-24-2014
version:
phs000200.v10.p3
dateModified:
09-26-2014
abbreviation:
NHLBI
name:
National Heart, Lung, and Blood Institute DAC
ID:
0
name:
dbGaP