Table 2.
Effect of zinc supplementation dose on diarrhea and vomiting in children with acute diarrhea.
| 5 mg | 10 mg | 20 mg | ||
|---|---|---|---|---|
| Diarrhea Related Outcomes | ||||
| Diarrhea > 5 days (Intention to treat analysis) |
n/N (%) | 106 /1480 (7.2%) | 114 / 1480 (7.7%) | 96 / 1479 (6.5%) |
| Risk difference and upper bound of one-sided 98.75% CI1 | 0.7% (2.8%) | 1.2% (3.3%) | Ref | |
| Non-inferiority one-sided p-value (+4% margin) | <0.001 | 0.002 | Ref | |
| Diarrhea > 5 days (Per protocol analysis) |
n/N (%) | 102 / 1431 (7.1%) | 109 /1437 (7.6%) | 93 /1440 (6.5%) |
| Risk difference and upper bound of one-sided 98.75% CI | 0.7% (2.8%) | 1.1% (3.3%) | Ref. | |
| Total loose or watery stools after enrolment (Intention to treat analysis) | N | 1496 | 1488 | 1490 |
| Mean + SD | 10.8 ± 8.9 | 10.9 ± 9.2 | 10.7 ± 8.7 | |
| Mean difference and upper bound of one-sided 98.75% CI1 | 0.1 (0.8) | 0.3 (1.0) | Ref | |
| Non-inferiority one-sided p-value (+2 stool margin) |
<0.001 | <0.001 | ||
| Total loose or watery stools after enrolment (Per protocol analysis) | N | 1431 | 1437 | 1410 |
| Mean + SD | 10.8 ± 8.9 | 11.0 ± 9.3 | 10.6 ± 8.2 | |
| Mean difference and upper bound of one-sided 98.75% CI | 0.2 (0.9) | 0.3 (1.1) | Ref. | |
| Vomiting Related Outcomes | ||||
| Proportion of children who ever vomited over 14 days within 30 minutes of dosing | n/N% | 206 / 1504 (13.7) | 233 / 1498 (15.6) | 289 / 1498 (19.3) |
| Relative risk (97.5% CI)2 | 0.71 (0.59-0.86) | 0.81 (0.67-0.96) | Ref. | |
| Superiority two-sided p-value2 | <0.001 | 0.007 | ||
| Proportion of children who ever vomited over 14 days after 30 minutes of dosing) | n/N% | 301 / 1496 (20.1) | 333 / 1488 (22.4) | 403 / 1490 (27.0) |
| Relative risk (95% CI) | 0.74 (0.65-0.85) | 0.83(0.73-0.94) | Ref. | |
1
A post-hoc Bonferroni correction was applied to the primary efficacy outcomes account for tests of the two efficacy outcomes and two treatment arms; 98.75% confidence intervals are presented and statistical significance of P-values should be assessed at a P < 0.0125 (0.05 / 4 tests).
2
A post-hoc Bonferroni correction was applied to the primary safety outcome account for tests of the two treatment arms; 97.5% confidence intervals are presented and statistical significance of P-values should be assessed at a P < 0.025 (0.05 / 2 tests).