Table 3.
Total adverse events through end of study by group.
| Vitamin D3 (n = 1211) | Placebo (n = 1212) | Incidence rate ratio with vitamin D (95% CI) | |||
|---|---|---|---|---|---|
| Events | Events per 100 person-years | Events | Events per 100 person-years | ||
| no. | no. | ||||
| Adverse event | 4039 | 116.1 | 4265 | 123.6 | 0.94 (0.90, 0.98) |
| Serious adverse event | 260 | 7.47 | 269 | 7.80 | 0.96 (0.81, 1.14) |
| Death | 5 | 0.14 | 6 | 0.17 | 0.83 (0.25, 2.71) |
| Hospitalization (new or prolongation) | 250 | 7.18 | 264 | 7.65 | 0.94 (0.79, 1.12) |
| Any adverse event leading to discontinuation of study pills | 58 | 1.67 | 46 | 1.33 | 1.25 (0.85, 1.84) |
| Within-study laboratory evaluation (confirmed with repeated testing) | |||||
| Hypercalcemia | 6 | 0.17 | 4 | 0.12 | 1.49 (0.42, 5.27) |
| Hypercalciuria | 1 | 0.03 | 1 | 0.03 | 0.99 (0.06, 15.86) |
| Low estimated glomerular filtration rate | 1 | 0.03 | 2 | 0.06 | 0.50 (0.04, 5.47) |
| Self-reported | |||||
| Nephrolithiasis | 28 | 0.80 | 24 | 0.70 | 1.16 (0.67, 2.00) |
Hypercalcemia was defined as serum calcium (uncorrected for albumin concentration) higher than the upper limit of the normal range for the clinical laboratory at each clinical site; hypercalciuria was defined as fasting morning urine calcium-creatinine ratio over 0.375 measured by the central laboratory; low estimated glomerular filtration rate was defined as equal to or lower than 30 mL per min per 1.73 m2 of body-surface based on serum creatinine measured at each clinical site’s clinical laboratory using the Chronic Kidney Disease Epidemiology Collaboration equation. Unless a specific threshold was reached, hypercalcemia, hypercalciuria and low estimated glomerular filtration rate required confirmation (see “Methods”).
Table includes events in all participants who underwent randomization regardless of adherence; analyses censored at death, withdrawal, or end-of-study encounter (visit or phone call).