W1 - CT core analytes on 6% subsample; Clinic CBC tests: Semi-annual core analytes on QC pools A and B

Investigator Names and Contact Information

Introduction/Intent

Subsample and core analytes were specified in the original WHI RFP.

All CT participants provided a blood sample at baseline and year 1. A 6% subsample of CT participants was randomly selected to provide additional blood samples at years 3, 6, and 9. This 6% subsample was adjusted as recruitment progressed to include a six-fold oversampling of racial/ethnic minority women while retaining a 6% subsampling in each Clinical Center. It selection also included a two-fold oversampling of HT (including HT and DM overlap) women (8.6%) as compared to DM-only women (4.3%).

A total of 4,546 participants were selected to be in this 6% subsample. The final numbers of the subsample women by racial/ethnic group and CT component are shown below. Note that the totals by race/ethnicity take into account the approximate 10-14% participants who are in both the HT and DM participants.

Native AmericanAsian/Pacific IslanderHispanicAfrican AmericanWhiteOther
HT631764076951,29659
DM751973138051,37355
Total1203375731,2002,22393

Each participant sample at each time point was tested for 20 ‘core analytes’. These include:

  • Lipids: total cholesterol, HDL, HDL2, HDL3, LDL, triglyceride, apolipoprotein(a)
  • Metabolic: glucose, insulin
  • Coagulation Factors: Factor VII Ag (antigen), Factor VII C (clotting activity); fibrinogen
  • Micronutrients: alpha-carotene, alpha-tocopherol, beta-carotene, beta-cryptoxanthine, gamma-tocopherol, lycopene, lutein+zeaxanthin, retinol

Results/Findings

Assay methodologies can be found here.

For summary data by analyte, see the 2005 progress report for a summary of core analyte values by baseline and years 1, 3, 6, and differences between baseline and years 1, 3, and 6 for HT and DM participants.

See publications: 204, 210, 222, 240, 273, 345, 347, 350, 447, 448, 449, 520, 521, 524, 866. WHI publications by study lists published WHI papers that have been generated by ancillary studies. A complete list of WHI papers is available in the Papers of this website.

Related Papers

Serum 25-hydroxyvitamin D concentrations in relation to cardiometabolic risk factors and metabolic syndrome in postmenopausal women

Sara Chacko et al., 2011/5 PubMed #21613558 MSID: 866
Low concentrations of serum 25-hydroxyvitamin D [25(OH)D] may be associated with cardiometabolic disorders; however, little is known about their relation to intermediate metabolic and lipid markers.We investigated the relation of serum 25(OH)D concentrations to fasting insulin, glucose, dyslipidemia, adiposity, and prevalent metabolic syndrome.We conducted this cross-sectional analysis in 292 postmenopausal women aged 50-79 y in the Women's Health Initiative Calcium-Vitamin D (WHI-CaD) trial. Da...
Keywords: Serum Vitamin D; 25-Hydroxyvitamin D; Insulin; Glucose; Lipids; High Density Lipoprotein (Hdl-C); Triglycerides; Inflammatory Cytokines; High Sensitivity C-Reactive Protein; Interleukin-6
Related Studies: W1, W6, W14

10-Year risk of atherosclerotic cardiovascular disease, hormone Therapy and cardiovascular disease outcomes in the Women’s Health Initiative hormone therapy trial

Approved Proposal, Nudy, Matthew et al., 2024/4 MSID: 5101
Keywords: Hormone Therapy; Cardiovascular Disease Risk; Pooled Cohort Equation; Coronary Heart Disease; Stroke
Related Studies: 422, W1, W6, W54, W58

Genetic ancestry and Lp(a) concentrations in menopausal women: a secondary analysis of the Women’s Health Initiative hormone therapy clinical trial

Approved Proposal, Nudy, Matthew et al., 2024/11 MSID: 5227
Keywords: Hormone Therapy; Estrogen; Estrogen Plus Progestin; Lipid; Glucose; Insulin; Biomarkers
Related Studies: W1, W54

Estrogen plus progestin and the risk of coronary heart disease

JoAnn Manson et al., 2003/8 PubMed #12904517 MSID: 210
Recent randomized clinical trials have suggested that estrogen plus progestin does not confer cardiac protection and may increase the risk of coronary heart disease (CHD). In this report, we provide the final results with regard to estrogen plus progestin and CHD from the Women's Health Initiative (WHI).The WHI included a randomized primary-prevention trial of estrogen plus progestin in 16,608 postmenopausal women who were 50 to 79 years of age at base line. Participants were randomly assigned t...
Keywords: Estrogen; Progestin; Coronary Heard Disease
Related Studies: W1, W6

Insulin level and risk of non-Hodgkin lymphoma among postmenopausal women in The Women’s Health Initiative

Approved Proposal, Peila, Rita et al., 2016/11 MSID: 3202
Keywords: Insulin; Type 2 Diabetes; Inflammation; C-Reactive Protein; Non-Hodgkin Lymphoma

Relation of pregnancy loss to risk of cardiovascular disease in parous postmenopausal women (from the Women’s Health Initiative)

Philip Hall et al., 2019/2 PubMed #30871746 MSID: 3204
Women with history of pregnancy loss (PL) have higher burden of cardiovascular disease (CVD) later in life, yet it is unclear whether this is attributable to an association with established CVD risk factors (RFs). We examined whether PL is associated with CVD RFs and biomarkers in parous postmenopausal women in the Women's Health Initiative, and whether the association between PL and CVD RFs accounted for the association between PL and incident CVD. Linear and logistic regressions were used to e...
Keywords: Pregnancy Loss; Cardiovascular Risk Factors; Inflammatory Biomarkers; Hemostatic Biomarkers; Diabetes
Related Studies: W1, W54, W58

Novel DNA methylation sites of glucose and insulin homeostasis: an integrative cross-omics analysis

Approved Manuscript, Liu, Jun et al., 2018/8 MSID: 3577
Keywords: Replication; Glucose; Insulin; Dna; Methylation; Ewas
Related Studies: 315, W1

Estrogen plus progestin and risk of venous thrombosis

Mary Cushman et al., 2004/10 PubMed #15467059 MSID: 222
Postmenopausal hormone therapy increases the risk of venous thrombosis. It is not known whether other factors influencing thrombosis add to this risk.To report final data on incidence of venous thrombosis in the Women's Health Initiative Estrogen Plus Progestin clinical trial and the association of hormone therapy with venous thrombosis in the setting of other thrombosis risk factors.Double-blind randomized controlled trial of 16,608 postmenopausal women between the ages of 50 and 79 years, who ...
Keywords: E+P; Vte
Related Studies: W1, W6

Effect of estrogen plus progestin on stroke in postmenopausal women: the Women’s Health Initiative: A randomized trial

Sylvia Smoller et al., 2003/5 PubMed #12771114 MSID: 204
The Women's Health Initiative (WHI) trial of estrogen plus progestin was stopped early because of adverse effects, including an increased risk of stroke in the estrogen plus progestin group.To assess the effect of estrogen plus progestin on ischemic and hemorrhagic stroke and in subgroups, and to determine whether the effect of estrogen plus progestin was modified by baseline levels of blood biomarkers.Multicenter double-blind, placebo-controlled, randomized clinical trial involving 16 608 women...
Keywords: Stroke; Estrogen; Progestin; Hrt; Clinical Trial
Related Studies: W1, W6

Venous thrombosis and conjugated equine estrogen in women without a uterus

J. David Curb et al., 2006/4 PubMed #16606815 MSID: 350
Postmenopausal hormone therapy has been associated with a 2- to 3-fold increased risk of venous thromboembolism (VT) (including deep vein thrombosis and pulmonary embolism) in observational studies and secondary prevention clinical trials. Clinical trial data on the effects of estrogen alone on VT are limited.The Women's Health Initiative estrogen trial enrolled 10 739 women aged 50 to 79 years without a uterus. Participants were randomly assigned to receive conjugated equine estrogen (0.625 mg/...
Keywords: Hormone Replacement Therapy; Estrogen; Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism; Coagulation; Fibrinolysis
Related Studies: W1, W6

Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results From the Women's Health Initiative randomized controlled trial

Jacques Rossouw et al., 2002/7 PubMed #12117397 MSID: 240
Despite decades of accumulated observational evidence, the balance of risks and benefits for hormone use in healthy postmenopausal women remains uncertain.To assess the major health benefits and risks of the most commonly used combined hormone preparation in the United States.Estrogen plus progestin component of the Women's Health Initiative, a randomized controlled primary prevention trial (planned duration, 8.5 years) in which 16608 postmenopausal women aged 50-79 years with an intact uterus a...
Keywords: E+P
Related Studies: W1

Conjugated equine estrogens and coronary heart disease: The Women's Health Initiative

Judith Hsia et al., 2006/2 PubMed #16476878 MSID: 345
In recent randomized trials, conjugated equine estrogens (CEE) with continuous medroxyprogesterone acetate provided no protection against coronary heart disease in postmenopausal women and may have increased cardiac risk. These trials did not address the role of unopposed estrogen for coronary protection.A total of 10 739 women aged 50 to 79 years at baseline (mean age, 63.6 years) who had previously undergone hysterectomy were randomized to receive CEE, 0.625 mg/d, or placebo at 40 US clinical ...
Keywords: Cee; Coronary Events; Myocardial Infarction; Coronary Death; Postmenopausal Women; Risk Factors; Hrt
Related Studies: W1, W6

Effects of conjugated equine estrogen in postmenopausal women with hysterectomy. The Women’s Health Initiative randomized controlled trial

Garnet Anderson et al., 2004/4 PubMed #15082697 MSID: 273
Despite decades of use and considerable research, the role of estrogen alone in preventing chronic diseases in postmenopausal women remains uncertain.To assess the effects on major disease incidence rates of the most commonly used postmenopausal hormone therapy in the United States.A randomized, double-blind, placebo-controlled disease prevention trial (the estrogen-alone component of the Women's Health Initiative [WHI]) conducted in 40 US clinical centers beginning in 1993. Enrolled were 10 739...
Keywords: Estrogen; Hormone Replacement Therapy; Postmenopausal; Primary Prevention; Cardiovascular Disease; Cancer; Fractures
Related Studies: W1, W6

Low-fat dietary pattern and risk of cardiovascular disease: The Women’s Health Initiative Randomized Controlled Dietary Modification Trial

Barbara Howard et al., 2006/2 PubMed #16467234 MSID: 447
Multiple epidemiologic studies and some trials have linked diet with cardiovascular disease (CVD) prevention, but long-term intervention data are needed.To test the hypothesis that a dietary intervention, intended to be low in fat and high in vegetables, fruits, and grains to reduce cancer, would reduce CVD risk.Randomized controlled trial of 48,835 postmenopausal women aged 50 to 79 years, of diverse backgrounds and ethnicities, who participated in the Women's Health Initiative Dietary Modifica...
Keywords: Low-Fat Dietary Pattern; Cardiovascular Disease; Randomized Controlled Trial
Related Studies: W1

Effects of conjugated equine estrogen on stroke in the Women's Health Initiative

Susan Hendrix et al., 2006/5 PubMed #16702472 MSID: 347
The Women's Health Initiative (WHI) Estrogen Alone trial assessed the balance of benefits and risks of hormone use in healthy postmenopausal women. The trial was stopped prematurely because there was no benefit for coronary heart disease and an increased risk of stroke. This report provides a thorough analysis of the stroke finding using the final results from the completed trial database.The WHI Estrogen Alone hormone trial is a multicenter, double-blind, placebo-controlled, randomized clinical...
Keywords: Hrt; Stroke; E Alone; Estrogen Plus Progestin
Related Studies: W1, W6

Low-fat dietary pattern and risk of colorectal cancer: the Women's Health Initiative randomized controlled dietary modification trial

Shirley Beresford et al., 2006/2 PubMed #16467233 MSID: 449
Observational studies and polyp recurrence trials are not conclusive regarding the effects of a low-fat dietary pattern on risk of colorectal cancer, necessitating a primary prevention trial.To evaluate the effects of a low-fat eating pattern on risk of colorectal cancer in postmenopausal women.The Women's Health Initiative Dietary Modification Trial, a randomized controlled trial conducted in 48,835 postmenopausal women aged 50 to 79 years recruited between 1993 and 1998 from 40 clinical center...
Keywords: Low-Fat Dietary Pattern; Colorectal Cancer; Randomized Controlled Trial
Related Studies: W1

Low-fat dietary pattern and risk of invasive breast cancer: The Women’s Health Initiative Randomized Controlled Dietary Modification Trial

Ross Prentice et al., 2006/2 PubMed #16467232 MSID: 448
The hypothesis that a low-fat dietary pattern can reduce breast cancer risk has existed for decades but has never been tested in a controlled intervention trial.To assess the effects of undertaking a low-fat dietary pattern on breast cancer incidence.A randomized, controlled, primary prevention trial conducted at 40 US clinical centers from 1993 to 2005.A total of 48,835 postmenopausal women, aged 50 to 79 years, without prior breast cancer, including 18.6% of minority race/ethnicity, were enrol...
Keywords: Low-Fat Dietary Pattern; Breast Cancer; Randomized Controlled Trial
Related Studies: W1, W33

Metabolic obesity phenotype, age acceleration and obesity-related cancer risk in the Women’s Health Initiative

Approved Proposal, Karra, Prasoona et al., 2023/3 MSID: 4878
Keywords: Obesity-Associated Cancer; Metabolic Dysfunction; Body Mass Index; Metabolic Health Phenotypes; Age Acceleration
Related Studies: 311, 315, 564, BA23, W1, W2, W54, W58, W66

The influence of vasomotor symptoms, age, and cardiometabolic status on effects of menopausal hormone therapy on cardiovascular disease: the Women’s Health Initiative Randomized Clinical Trials

Approved Manuscript, Rossouw, Jacques et al., 2024/9 MSID: 4962
Keywords: Coronary Heart Disease; Vasomotor Symptoms; Hormone Therapy; Lipids; Metabolic Syndrome; Stroke; All-Cause Mortality
Related Studies: 422, W1, W6, W11, W54, W58

Long-Term Changes to Cardiovascular Biomarkers After Hormone Therapy in the Women's Health Initiative Hormone Therapy Clinical Trials

Matthew Nudy et al., 2025/2 PubMed #40014858 MSID: 5084
Objective: To assess the long-term changes in cardiovascular biomarkers during the WHI (Women's Health Initiative) hormone therapy (HT) clinical trials of conjugated equine estrogens (CEE) alone and CEE plus medroxyprogesterone acetate (MPA). Methods: HT trial participants from the CEE alone (n=1,188, 0.625 mg/d CEE or placebo) and the CEE+MPA (n=1,508, 0.625 mg/d CEE plus continuous 2.5 mg/d MPA or placebo) trials provided blood samples at baseline and after 1, 3, and 6 years. Low-density lipop...
Keywords: Hormone Therapy; Estrogen; Estrogen Plus Progestin; Lipid; Glucose; Insulin; Biomarkers
Related Studies: W1