Table 1.
Baseline Characteristics of Participants Grouped by Treatment Assignment.
Characteristics | Calcium/Vitamin D N=2034 | Placebo N=2109 | P-value |
---|---|---|---|
| |||
Age at screening, years | |||
Mean age | 70.7 | 70.9 | 0.22 |
65–69 | 1003 (49.4%) | 984 (46.7%) | |
70–74 | 692 (34.1%) | 774 (36.7%) | 0.16 |
75–80 | 337 (16.6%) | 351 (16.6%) | |
| |||
Race/ethnicity | |||
American Indian/Alaskan | 9 (0.4%) | 7 (0.3%) | |
Native | |||
Asian/Pacific Islander | 37 (1.8%) | 38 (1.8%) | |
Black/African-American | 128 (6.3%) | 121 (5.7%) | |
Hispanic/Latino | 41 (2.0%) | 59 (2.8%) | 0.61 |
White, non-Hispanic | 1792 (88.2%) | 1859 (88.2%) | |
Other | 26 (1.3%) | 25 (1.2%) | |
| |||
Education | |||
Not high school grad | 141 (7.0%) | 146 (6.9%) | |
High school grad | 444 (21.9%) | 469 (22.2%) | 0.98 |
Post-HS | 812 (40.0%) | 847 (40.2%) | |
College graduate | 633 (31.2%) | 647 (30.7%) | |
| |||
Medical co-morbidity | |||
History of myocardial infarction | 63 (3.1%) | 68 (3.2%) | 0.82 |
History of stroke or TIA | 75 (3.7%) | 69 (3.3%) | 0.47 |
Diabetes | 148 (7.3%) | 167 (7.9%) | 0.43 |
Hypertension | 986 (48.5%) | 1029 (48.8%) | 0.84 |
| |||
Body mass index, kg/m2 | |||
< 25.0 | 565 (28.0%) | 599 (28.5%) | |
25.0–29.9 | 729 (36.1%) | 741 (35.3%) | 0.84 |
≥ 30.0 | 724 (35.9%) | 761 (36.2%) | |
| |||
Cigarette smoking | |||
Never | 1039 (51.8%) | 1174 (56.3%) | |
Former | 809 (40.4%) | 784 (37.6%) | 0.007 |
Current | 156 (7.8%) | 127 (6.1%) | |
| |||
Alcohol use, drinks/day | |||
None | 946 (46.6%) | 964 (45.8) | |
≤2 | 990 (48.8%) | 1061 (50.4) | 0.36 |
>2 | 92 (4.5%) | 80 (3.8) | |
| |||
Burnam score for depressive symptoms | |||
≤0.06 | 1880 (92.4%) | 1953 (92.6%) | 0.83 |
>0.06 | 154 (7.6%) | 156 (7.4%) | |
| |||
Recreational physical activity, METS/week | |||
0–3.5 | 657 (32.4%) | 674 (32.0%) | |
3.6–12.5 | 673 (33.2%) | 729 (34.6%) | 0.59 |
≥12.5 | 699 (34.4%) | 702 (33.4%) | |
| |||
Supplement use | |||
Calcium | 1061 (52.2%) | 1196 (56.7%) | 0.003 |
Vitamin D | 929 (45.7%) | 1047 (49.6%) | 0.01 |
| |||
Dietary calcium intake, mg/day* | |||
<600 | 686 (38.7%) | 702 (38.0%) | |
600–799 | 359 (20.2%) | 351 (19.0%) | 0.61 |
800–1199 | 447 (25.2%) | 480 (26.0%) | |
≥1200 | 281 (15.8%) | 315 (17.0%) | |
| |||
Total calcium intake (supplements + diet), mg/day | |||
<600 | 423 (23.9%) | 435 (23.5%) | |
600–799 | 259 (14.6%) | 241 (13.0%) | 0.26 |
800–1199 | 463 (26.1%) | 464 (25.1%) | |
≥1200 | 628 (35.4%) | 708 (38.3%) | |
| |||
Dietary vitamin D intake, IU/day | |||
<200 | 380 (21.4%) | 355 (19.2%) | |
200–399 | 594 (33.5%) | 646 (35.0%) | 0.08 |
400–599 | 444 (25.0%) | 430 (23.3%) | |
≥600 | 355 (20.0%) | 417 (22.6%) | |
| |||
Total vitamin D intake (supplements + diet), IU/day | |||
<200 | 256 (14.4%) | 227 (12.3%) | |
200–399 | 213 (12.0%) | 197 (10.7%) | 0.09 |
400–599 | 331 (18.7%) | 348 (18.8%) | |
≥600 | 973 (54.9%) | 1076 (58.2%) | |
| |||
Dietary modification trial assignment | |||
Control | 306 (15.0%) | 301 (14.3%) | |
Intervention | 178 (8.8%) | 228 (10.8%) | 0.08 |
Not in trial | 1550 (76.2%) | 1580 (74.9%) | |
| |||
HT treatment assignment | |||
CEE-alone placebo | 385 (18.9%) | 415 (19.7%) | |
CEE-alone | 396 (19.5%) | 367 (17.4%) | 0.06 |
CEE+MPA placebo | 587 (28.9%) | 677 (32.1%) | |
CEE+MPA | 666 (32.7%) | 650 (30.8%) | |
| |||
Adherence to HT study drugb | |||
<80% adherent | 500 (24.6%) | 507 (24.1%) | 0.67 |
≥80% adherent | 1529 (75.4%) | 1599 (75.9%) | |
| |||
Adherence to CaD study drugb | |||
<80% adherent | 555 (27.7%) | 509 (24.5%) | 0.02 |
≥80% adherent | 1446 (72.3%) | 1566 (75.5%) | |
| |||
WHISCA enrollment | |||
No | 1344 (66.1%) | 1379 (65.4%) | 0.64 |
Yes | 690 (33.9%) | 730 (34.6%) | |
| |||
Baseline 25(OH)D level, ng/mL | |||
Sample size | N=150 | N=143 | |
Mean level (± SD) | 20.0 (± 8.8) | 19.2 (± 8.4) | 0.36c |
Tertile 1 (<15.0) | 49 (32.7%) | 49 (34.3%) | |
Tertile 2 (15.0–22.5) | 52 (34.7%) | 46 (32.2%) | 0.90 |
Tertile 3 (>22.5) | 49 (32.7%) | 48 (33.6%) |
Data are expressed as number (percentage) unless otherwise specified. Numbers across categories may not sum to the given totals because of missing data.
Mean adherence throughout follow-up.
Based on log-transformed levels.