Table 2.
Baseline characteristics for the subsample with blood collections of the 2×2 factorial portion of the WHI HT and Calcium + Vitamin D trials (n = 1,521) by randomization group
| Placebo (n=394) | Calcium + Vitamin D-alone (n=376) | Hormone Therapy-alone (n=373) | Hormone Therapy+Calcium + Vitamin D (n=378) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Characteristic | N | % | N | % | N | % | N | % | P-Value |
| Age at screening, y, mean (SD) | 62.3 | (7.4) | 61.7 | (7.0) | 62.0 | (7.0) | 62.3 | (6.8) | 0.61 |
| Age group at screening (10 yr intervals) | 0.44 | ||||||||
| 50-59 | 162 | 41.1 | 157 | 41.8 | 154 | 41.3 | 141 | 37.3 | |
| 60-69 | 154 | 39.1 | 163 | 43.4 | 153 | 41.0 | 171 | 45.2 | |
| 70-79 | 78 | 19.8 | 56 | 14.9 | 66 | 17.7 | 66 | 17.5 | |
| Race/ethnicity | 0.13 | ||||||||
| White | 186 | 47.2 | 169 | 44.9 | 190 | 50.9 | 199 | 52.6 | |
| Black | 114 | 28.9 | 101 | 26.9 | 89 | 23.9 | 79 | 20.9 | |
| Other | 94 | 23.9 | 106 | 28.2 | 94 | 25.2 | 100 | 26.5 | |
| Hormone use | 0.77 | ||||||||
| Never used | 267 | 67.8 | 245 | 65.2 | 255 | 68.4 | 263 | 69.6 | |
| Past user | 97 | 24.6 | 92 | 24.5 | 84 | 22.5 | 85 | 22.5 | |
| Current user1 | 30 | 7.6 | 39 | 10.4 | 34 | 9.1 | 30 | 7.9 | |
| Baseline vasomotor symptoms, % | 0.50 | ||||||||
| None | 202 | 51.4 | 203 | 54.6 | 205 | 55.4 | 203 | 54.4 | |
| Mild | 127 | 32.3 | 99 | 26.6 | 106 | 28.6 | 99 | 26.5 | |
| Moderate/severe | 64 | 16.3 | 70 | 18.8 | 59 | 15.9 | 71 | 19.0 | |
| Body mass index, kg/m2, median (IQR) | 29.1 (25.2, 33.1) | 28.9 (25.3, 34.2) | 28.9 (24.9, 33.4) | 29.4 (25.3, 34.0) | 0.69 | ||||
| Smoking. % | 0.15 | ||||||||
| Never | 216 | 55.5 | 176 | 47.7 | 206 | 55.7 | 213 | 57.0 | |
| Past | 128 | 32.9 | 151 | 40.9 | 130 | 35.1 | 124 | 33.2 | |
| Current | 45 | 11.6 | 42 | 11.4 | 34 | 9.2 | 37 | 9.9 | |
| Hysterectomy, % | 175 | 44.4 | 160 | 42.6 | 158 | 42.4 | 157 | 41.5 | 0.87 |
| Bilateral oophorectomy, % | 71 | 18.5 | 68 | 19.0 | 54 | 15.0 | 54 | 15.0 | 0.30 |
| Medical treatment, % | |||||||||
| Treated for diabetes | 21 | 5.3 | 30 | 8.0 | 23 | 6.2 | 28 | 7.4 | 0.46 |
| Hypertensive or BP ≥140/90 | 164 | 43.4 | 182 | 49.3 | 164 | 46.7 | 169 | 47.5 | 0.43 |
| High cholesterol levels (medication) | 42 | 10.7 | 53 | 14.1 | 37 | 9.9 | 44 | 11.6 | 0.30 |
| Statin use at baseline | 20 | 5.1 | 32 | 8.5 | 17 | 4.6 | 24 | 6.3 | 0.11 |
| Aspirin use (≥80mg/d) at baseline | 71 | 18.0 | 62 | 16.5 | 58 | 15.5 | 72 | 19.0 | 0.59 |
| Medical History, % | |||||||||
| Myocardial infarction | 8 | 2.0 | 4 | 1.1 | 5 | 1.3 | 9 | 2.4 | 0.48 |
| Angina | 18 | 4.6 | 14 | 3.8 | 13 | 3.5 | 22 | 5.9 | 0.39 |
| CABG/PCI2 | 6 | 1.5 | 3 | 0.8 | 1 | 0.3 | 6 | 1.6 | 0.24 |
| Stroke | 8 | 2.0 | 7 | 1.9 | 5 | 1.3 | 1 | 0.3 | 0.15 |
| Deep vein thrombosis or pulmonary embolism | 3 | 0.8 | 4 | 1.1 | 2 | 0.5 | 3 | 0.8 | 0.88 |
| Family history of breast cancer | 53 | 14.6 | 51 | 15.0 | 63 | 17.9 | 50 | 13.9 | 0.46 |
| > High school degree/GED | 278 | 70.9 | 253 | 68.2 | 269 | 72.9 | 268 | 71.3 | 0.56 |
| Family income ≥ $50,000, % | 97 | 26.2 | 82 | 23.4 | 102 | 29.2 | 96 | 26.4 | 0.39 |
| LDL-C (mg/dL), mean (SD) | 140.3 | (36.8) | 136.1 | (34.1) | 140.4 | (34.2) | 140.0 | (35.1) | 0.28 |
| HDL-C (mg/dL), mean (SD) | 56.0 | (14.1) | 55.5 | (13.9) | 57.3 | (14.6) | 56.4 | (14.3) | 0.36 |
| Triglyceride (mg/dL), median (IQR) | 128.0 (95.0, 169.0) | 126.0 (98.0, 174.0) | 127.0 (93.5, 176.5) | 128.0 (93.0, 173.0) | 0.90 | ||||
| Total cholesterol (mg/dL) mean (SD) | 225.9 | (39.8) | 220.4 | (37.6) | 226.7 | (36.7) | 225.8 | (38.8) | 0.10 |
| Glucose (mg/dL), median (IQR) | 96.0 (89.0, 105.0) | 95.5 (89.0, 106.0) | 94.0 (88.5, 104.0) | 96.0 (89.0, 106.0) | 0.37 | ||||
| Insulin (uIU/ml), median (IQR) | 10.6 (7.9, 15.6) | 10.9 (7.6, 15.9) | 10.3 (7.5, 14.3) | 10.5 (7.4 15.6) | 0.47 | ||||
| Systolic BP (mm Hg), mean (SD) | 127.6 | (17.2) | 127.0 | (16.9) | 129.6 | (17.4) | 129.0 | (18.1) | 0.15 |
| Diastolic BP (mm Hg), mean (SD) | 76.1 | (9.1) | 76.6 | (9.5) | 76.5 | (8.6) | 76.0 | (9.6) | 0.78 |
| Weight (kg), mean (SD) | 77.7 | (16.8) | 78.7 | (18.5) | 76.9 | (17.7) | 77.2 | (18.5) | 0.53 |
| Height (cm), mean (SD) | 160.9 | (7.7) | 161.1 | (7.4) | 160.8 | (6.8) | 159.9 | (7.4) | 0.09 |
| Waist/hip ratio, median (IQR) | 0.82(0.77, 0.87) | 0.83 (0.78, 0.88) | 0.82 (0.77, 0.88) | 0.82 (0.78, 0.87) | 0.46 | ||||
| Waist (cm), mean (SD) | 90.3 | (13.2) | 91.0 | (14.2) | 89.5 | (13.6) | 90.6 | (14.4) | 0.51 |
1
Required a 3-month washout prior to randomization
2
CABG/PCI=coronary artery bypass graft/percutaneous coronary intervention
HORMONE THERAPY=Hormone therapy,