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 American | Asian/Pacific Islander | Hispanic | African American | White | Other | |
|---|---|---|---|---|---|---|
| HT | 63 | 176 | 407 | 695 | 1,296 | 59 |
| DM | 75 | 197 | 313 | 805 | 1,373 | 55 |
| Total | 120 | 337 | 573 | 1,200 | 2,223 | 93 |
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
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Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results From the Women's Health Initiative randomized controlled trial
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The Women's Health Initiative recruitment methods and results
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Effects of conjugated equine estrogen on stroke in the Women's Health Initiative
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Low-fat dietary pattern and risk of invasive breast cancer: The Women’s Health Initiative Randomized Controlled Dietary Modification Trial
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...
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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
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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...
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