Table 4. Effect of micronutrient supplementation on tuberculosis compared to placebo early in HIV disease.
| Study arms | Number without TB event/total × 100 (% censored)a | Number of TB casesb | HRc | 95% HR confidence intervals | P-value |
|---|---|---|---|---|---|
| Placebo | 207/217 × 100 (95.3%) | 10 | 1 | ||
| Multivitamin | 214/219 × 100 (97.7%) | 5 | 0.58 | (0.19, 1.74) | 0.33 |
| Selenium | 216/219 × 100 (98.6%) | 3 | 0.20 | (0.04, 0.95) | 0.043* |
| Multivitamins + selenium | 214/220 × 100 (97.3%) | 6 | 0.46 | (0.14, 1.50) | 0.20 |
| Selenium arm combined with multivitamins + selenium arm | 430/439 × 100 (97.9%) | 9 | 0.32 | (0.11, 0.93) | 0.036* |
Notes:
Percent censored events indicates the percentage of participants who completed 24 months of the study without endpoint in the numerator and the number of participants who entered in the primary analyses in the denominator.
Frequency of clinical events is the difference between total number of participants included in the analyses and those who finished the 24 months without event of TB.
HRs by the risk of tuberculosis for the three supplementation arms compared to placebo, for the 24 months trial duration. Cox's proportional hazards model was used to examine the effect of selenium and multivitamin supplementations, individually or jointly, on tuberculosis compared to placebo. Age, gender, baseline BMI, baseline CD4 cell count and baseline HIV viral load were controlled for in all the analyses.
Significant.
Abbreviations: BMI, body mass index; HR, hazard ratio; TB, tuberculosis.