Table 3.
Effect modification of vitamin D3 supplementation on mortality by pre-specified baseline factors
| Vitamin D n / N (%) |
Placebo n / N (%) |
Hazard Ratio (95% CI) | p-value for effect modification | |
|---|---|---|---|---|
| All participants | 211 / 2001 (10.5) | 204 / 1999 (10.2) | 1.04 (0.85–1.25) | - |
| Subgroups | ||||
| Sex | ||||
| Male | 105 / 634 (16.6) | 93 / 631 (14.7) | 1.13 (0.85–1.49) | 0.39 |
| Female | 106 / 1367 (7.8) | 111 /1368 (8.1) | 0.96 (0.73–1.25) | |
| Age | ||||
| < 40 years | 101 / 1176 (8.6) | 90 / 1130 (8.0) | 1.08 (0.82–1.44) | 0.73 |
| ≥ 40 years | 110 / 825 (13.3) | 114 / 755 (13.1) | 1.01 (0.78–1.32) | |
| CD4 T-cell count | ||||
| < 200 cells per μL | 134 / 866 (15.5) | 141 / 845 (16.7) | 0.91 (0.72–1.15) | 0.18 |
| ≥ 200 cells per μL | 60 / 1045 (5.7) | 44 / 1056 (4.2) | 1.40 (0.95–2.06) | |
| Missing | 17 / 90 (18.9) | 19 / 98 (19.4) | 0.98 (0.51–1.90) | |
| WHO HIV disease stage | ||||
| I / II | 29 / 744 (3.9) | 38 / 760 (5.0) | 0.78 (0.48–1.26) | 0.0053 |
| III | 160 / 1161 (13.8) | 128 / 1143 (11.2) | 1.24 (0.98–1.57) | |
| IV | 22 / 96 (22.9) | 38 / 96 (39.6) | 0.52 (0.31–0.89) | |
| Baseline pulmonary TB | ||||
| Yes | 23 / 189 (12.2) | 35 / 175 (20.0) | 0.59 (0.35–1.00) | 0.025 |
| No | 188 / 1812 (10.4) | 169 / 1824 (9.3) | 1.12 (0.91–1.38) | |
| Body mass index | ||||
| <18.5 kg/m2 | 94 / 440 (21.4) | 83 / 404 (20.5) | 1.13 (0.85–1.49) | 0.70 |
| ≥ 18.5 kg/m2 | 115 / 1559 (7.4) | 121 / 1595 (7.6) | 0.96 (0.73–1.25) | |
| Vitamin D status at screening visit | ||||
| Deficient 25(OH)D 0–19.9 ng/mL | 104 / 1046 (9.9) | 98 / 1027 (9.5) | 1.05 (0.80–1.38) | 0.88 |
| Insufficient 25(OH)D 20.0–29.9 ng/mL | 107 / 955 (11.2) | 106 / 972 (10.9) | 1.02 (0.78–1.33) | |
| Adherence to randomized trial regimen | ||||
| High – 100% on weekly doses and ≥90% on daily doses | 103 / 876 (11.8) | 110 / 889 (12.4) | 0.95 (0.72–1.24) | 0.35 |
| Low – <100% on weekly doses or < 90% on daily doses | 108 / 1125 (9.6) | 94 / 1110 (8.5) | 1.14 (0.87–1.50) | |