Table 3.
Hazard Ratios (HR) and 95% Confidence Intervals (CI) of the Primary Outcomes Comparing Vitamin D (Vit D) and Placebo Groups, According to Baseline Characteristics (Prespecified Subgroups) in Intention-To-Treat Analyses
| Total Invasive Cancer | Major Cardiovascular Events | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| N Events | Inter-action P-value | N Events | Inter-action P-value | ||||||
| Subgroup | Total | Vit D | Placebo | HR (95%CI) | Vit D | Placebo | HR (95%CI) | P-value | |
| Age (years) | 25871 | 0.73 | 0.31 | ||||||
| <median (66.7) | 12859 | 302 | 322 | 0.95 (0.81–1.11) | 140 | 131 | 1.07 (0.85–1.36) | ||
| ≥median (66.7) | 13012 | 491 | 502 | 0.98 (0.86–1.11) | 256 | 278 | 0.93 (0.78–1.10) | ||
| Sex | 25871 | 0.38 | 0.57 | ||||||
| Male | 12786 | 452 | 488 | 0.93 (0.82–1.06) | 223 | 223 | 1.01 (0.84–1.21) | ||
| Female | 13085 | 341 | 336 | 1.02 (0.87–1.18) | 173 | 186 | 0.93 (0.76–1.14) | ||
| Race | 25304 | 0.21 | 0.37 | ||||||
| Non-Hispanic White | 18046 | 626 | 632 | 0.99 (0.89–1.11) | 280 | 301 | 0.93 (0.79–1.10) | ||
| African American | 5106 | 98 | 126 | 0.77 (0.59–1.01) | 69 | 76 | 0.91 (0.65–1.26) | ||
| Other | 2152 | 53 | 52 | 1.03 (0.70–1.51) | 32 | 24 | 1.36 (0.80–2.31) | ||
| Body Mass Index (kg/m2) | 25254 | 0.002 | 0.66 | ||||||
| <25 | 7843 | 206 | 278 | 0.76 (0.63–0.90) | 117 | 115 | 1.07 (0.83–1.38) | ||
| 25–<30 | 10122 | 338 | 323 | 1.04 (0.90–1.21) | 152 | 162 | 0.93 (0.74–1.16) | ||
| ≥30 | 7289 | 228 | 199 | 1.13 (0.94–1.37) | 120 | 120 | 0.98 (0.76–1.26) | ||
| Body Mass Index (kg/m2) | 25254 | 0.026 | 0.89 | ||||||
| <median (27.1) | 12582 | 361 | 421 | 0.86 (0.75–0.99) | 189 | 193 | 0.99 (0.81–1.21) | ||
| ≥median (27.1) | 12672 | 411 | 379 | 1.08 (0.94–1.24) | 200 | 204 | 0.97 (0.80–1.18) | ||
| Baseline Serum 25(OH)Da | 15787 | 0.99 | 0.75 | ||||||
| <20 ng/mL | 2001 | 58 | 63 | 0.97 (0.68–1.39) | 34 | 34 | 1.09 (0.68–1.76) | ||
| ≥20 ng/mL | 13786 | 459 | 464 | 0.98 (0.86–1.12) | 218 | 216 | 1.00 (0.83–1.21) | ||
| Baseline serum 25(OH)Da | 15787 | 0.57 | 0.42 | ||||||
| <cohort median | 7812 | 251 | 252 | 1.02 (0.86–1.21) | 128 | 139 | 0.94 (0.74–1.20) | ||
| ≥cohort median | 7975 | 266 | 275 | 0.95 (0.80–1.12) | 124 | 111 | 1.09 (0.84–1.41) | ||
| Baseline Vitamin D useb | 25871 | 0.64 | 0.71 | ||||||
| Yes | 11030 | 370 | 376 | 0.99 (0.86–1.14) | 165 | 164 | 1.00 (0.81–1.25) | ||
| No | 14841 | 423 | 448 | 0.94 (0.83–1.08) | 231 | 245 | 0.95 (0.79–1.14) | ||
| Omega-3 Fatty Acids randomization statusc | 25871 | 0.56 | 0.56 | ||||||
| Placebo group | 12938 | 385 | 412 | 0.94 (0.82–1.08) | 210 | 209 | 1.01 (0.83–1.22) | ||
| Omega-3 group | 12933 | 408 | 412 | 0.99 (0.87–1.14) | 186 | 200 | 0.93 (0.76–1.14) | ||
a
Serum 25-hydroxyvitamin D levels: to convert 25(OH)D unit from ng/ml to nmol/L, multiply by 2.5. For median analyses, cutpoint was at 31 mg/mL.
b
Use of out-of-study vitamin D supplements at baseline (restricted to ≤800 IU/d from all sources combined, including individual supplements and multivitamins).
c
Randomization status in the trial.
From Cox regression models controlling for age, sex, and omega-3 randomization group. Analyses are not adjusted for multiple comparisons.