Table 3.
Hazard Ratios for Total Fractures with Vitamin D as Compared with Placebo, According to Subgroup.*
| Subgroup | No. of Participants | Vitamin D Group (N = 12,927) | Placebo Group (N = 12,944) | Hazard Ratio (95% CI) |
|---|---|---|---|---|
| no. of participants with event | ||||
| Age | ||||
| <Median of 66.7 yr | 12,859 | 282 | 285 | 0.99 (0.84–1.18) |
| ≥Median of 66.7 yr | 13,012 | 487 | 497 | 0.97 (0.86–1.10) |
| Sex | ||||
| Male | 12,786 | 265 | 250 | 1.07 (0.90–1.28) |
| Female | 13,085 | 504 | 532 | 0.94 (0.83–1.06) |
| Race or ethnic group | ||||
| Non-Hispanic White | 18,046 | 655 | 658 | 0.99 (0.89–1.11) |
| Black | 5,106 | 53 | 59 | 0.89 (0.62–1.30) |
| Other | 2,152 | 46 | 51 | 0.90 (0.61–1.35) |
| BMI category | ||||
| <25 | 7,849 | 300 | 327 | 0.93 (0.79–1.09) |
| 25 to <30 | 10,127 | 254 | 271 | 0.93 (0.78–1.11) |
| ≥30 | 7,294 | 198 | 165 | 1.17 (0.95–1.44) |
| BMI | ||||
| <Median of 27.1 | 12,589 | 435 | 456 | 0.95 (0.83–1.09) |
| ≥Median of 27.1 | 12,681 | 317 | 307 | 1.03 (0.88–1.20) |
| Osteoporosis medication† | ||||
| Yes | 1,240 | 62 | 79 | 0.74 (0.53–1.03) |
| No | 24,450 | 704 | 697 | 1.01 (0.91–1.12) |
| History of fragility fractures† | ||||
| Yes | 2,578 | 146 | 161 | 0.87 (0.69–1.09) |
| No | 22,445 | 598 | 595 | 1.01 (0.90–1.14) |
| Baseline use of supplemental vitamin D | ||||
| Yes | 11,030 | 393 | 399 | 0.97 (0.84–1.12) |
| No | 14,841 | 376 | 383 | 0.99 (0.86–1.14) |
| Supplemental calcium | ||||
| ≤1200 mg/day | 5,166 | 228 | 232 | 0.92 (0.77–1.11) |
| None | 20,705 | 541 | 550 | 1.00 (0.89–1.13) |
| Baseline 25-hydroxyvitamin D level, according to median | ||||
| <Median of 31 ng/ml | 8,430 | 239 | 241 | 1.02 (0.85–1.22) |
| ≥Median of 31 ng/ml | 8,327 | 329 | 344 | 0.93 (0.80–1.08) |
| Baseline 25-hydroxyvitamin D level in quartiles | ||||
| Quartile 1: ≤24.0 ng/ml | 4,270 | 115 | 112 | 1.04 (0.80–1.36) |
| Quartile 2: 24.1–30.0 ng/ml | 4,104 | 122 | 128 | 0.98 (0.77–1.26) |
| Quartile 3: 30.1–36.9 ng/ml | 4,097 | 151 | 154 | 0.98 (0.78–1.23) |
| Quartile 4: ≥37.0 ng/ml | 4,286 | 180 | 191 | 0.89 (0.73–1.10) |
| Baseline 25-hydroxyvitamin D level, according to threshold of 12 ng/ml† | ||||
| <12 ng/ml | 401 | 7 | 8 | 1.03 (0.36–2.95) |
| ≥12 ng/ml | 16,356 | 561 | 577 | 0.97 (0.86–1.09) |
| Randomization in the n–3 fatty acids portion of the trial | ||||
| Placebo group | 12,938 | 374 | 392 | 0.95 (0.82–1.09) |
| Active-agent group | 12,933 | 395 | 390 | 1.02 (0.88–1.17) |
*
Analyses were conducted with the use of Cox proportional-hazards models that were adjusted for age, sex, race or ethnic group, and n–3 fatty acid randomization group (intention-to-treat analyses). Confidence intervals were not adjusted for multiple comparisons, and inferences drawn from them may not be reproducible.
†
These subgroups were not prespecified, but a subgroup defined by a baseline 25-hydroxyvitamin D level of less than 10 ng per milliliter (201 participants) was prespecified.