Table 3.
Effect of zinc supplementation dose on secondary outcomes.
| Secondary Outcomes | |||||
|---|---|---|---|---|---|
| 5 mg (n=1504) Mean±SD or n(%) | Effect size (95% CI) | 10 mg (n=1498) Mean±SD or n(%) | Effect size (95% CI) | 20 mg (n=1498) Mean±SD or n(%) | |
| Proportion of children with SAEs within 60 days | 12 (0.8) | 1.00 (0.46,2.14) | 7 (0.5) | 0.69 (0.30,1.61) | 9 (0.6) |
| Proportion of children with diarrhoea continuing beyond 3 days (n=1481,1481,1480) | 333 (22.5) | 1.03 (0.90-1.18) | 333 (22.5) | 1.03 (0.90-1.18) | 323 (21.8) |
| Mean number of tablets consumed during 14 day treatment | 13.53±2.05 | -0.05 (-0.19,0.09) | 13.65±1.71 | 0.06 (-0.06,0.19) | 13.58±1.83 |
| Number of follow up visits with diarrhea in the 2week period before day 30,45 and 60 / Total number of follow up visits* | 233/4319 (5.4) | 0.87 (0.71,1.06) | 258/4351 (5.9) | 0.95 (0.79,1.15) | 269/4331 (6.2) |
| Proportion of children who had diarrhea in the 2-week period before day 30 (n=1433,1449,1437) | 104 (7.3) | 0.90 (0.70,1.16) | 104 (7.2) | 0.89 (0.69,1.15) | 116 (8.1) |
| Proportion of children who had diarrhea in the 2-week period before day45 (n=1434,1444,1447) | 60 (4.2) | 0.80 (0.57,1.11) | 77 (5.3) | 1.02 (0.75,1.38) | 76 (5.3) |
| Proportion of children who had diarrhea in the 2-week period before day 60 (n=1452,1458,1447) | 69 (4.8) | 0.89 (0.65,1.23) | 77 (5.3) | 0.99 (0.73,1.35) | 77 (5.3) |
| Number of follow up visits with fever in the 2-week period before day 30,45 and 60 / Total number of follow up visits1 | 388/4319 (9.0) | 0.99 (0.85,1.15) | 397/4351 (9.1) | 1.00 (0.86,1.16) | 394/4331 (9.1) |
| Proportion of children who had fever in the 2-week period before day 30 (n=1433,1449,1437) | 149 (10.4) | 1.12 (0.90,1.40) | 139 (9.6) | 1.04 (0.83,1.30) | 133 (9.3) |
| Proportion of children who had fever in the 2week period before day 45 (n=1434,1444,1447) | 113 (7.9) | 0.85 (0.67,1.08) | 124 (8.6) | 0.93 (0.73,1.17) | 134 (9.3) |
| Proportion of children who had fever in the 2week period before day 60 (n=1452,1458,1447) | 126 (8.7) | 0.99 (0.78,1.25) | 134 (9.2) | 1.05 (0.83,1.32) | 127 (8.8) |
| Number of follow up visits with fast or difficult breathing in the 2-week period before day 30,45 and 60 / Total number of follow up visits* | 26/4318 (0.60) | 1.19 (0.65,2.18) | 34/4351 (0.78) | 1.54 (0.85,2.79) | 22/4328 (0.51) |
| Proportion of children who had fast or difficult breathing in the 2-week period before day 30 (n=1432,1449,1436) | 8 (0.6) | 1.34 (0.47,3.84) | 10 (0.7) | 1.65 (0.60,4.53) | 6 (0.4) |
| Proportion of children who had fast or difficult breathing in the 2-week period before day 45 (n=1434,1444,1445) | 11 (0.8) | 1.23 (0.51,2.96) | 14 (1.0) | 1.56 (0.68,3.59) | 9 (0.6) |
| Proportion of children who had fast or difficult breathing in the 2-week period before day 60 (n=1452,1458,1447) | 7 (0.5) | 1.00 (0.35,2.83) | 10 (0.7) | 1.42 (0.54,3.71) | 7 (0.5) |
| Proportion of mothers who report of ease in supplement administration (n=1447,1453,1452) | 1187 (82.0) | 1.01 (0.97,1.04) | 1174 (80.8) | 0.99 (0.96,1.03) | 1182 (81.4) |
| Mean change in length (1356,1357,1357) | 1.54±0.89 | -0.04 (-0.11,0.03) | 1.58±0.89 | 0.003 (-0.06,0.07) | 1.58±0.90 |
| Mean change in weight (1367,1370,1363) | 0.51±0.42 | 0.03 (-0.002,0.06) | 0.50±0.41 | 0.02 (-0.007,0.05) | 0.48±0.41 |
| Mean change in MUAC (1345,1348,1356) | 0.33±0.45 | 0.03 (-0.007,0.06) | 0.33±0.46 | 0.03 (-0.004,0.07) | 0.30±0.46 |
| Mean change in LAZ/HAZ (1355,1357,1357) | -0.11±0.34 | -0.01 (-0.04,0.01) | -0.10±0.34 | -0.005 (-0.03,0.02) | -0.10±0.33 |
| Mean change in WAZ (1367,1370,1363) | 0.10±0.35 | 0.02 (-0.007,0.05) | 0.10±0.35 | 0.02 (-0.004,0.05) | 0.08±0.35 |
| Mean change in WLZ/WHZ (1354,1350,1360) | 0.19±0.54 | 0.03 (-0.01,0.07) | 0.18±0.55 | 0.03 (-0.01,0.07) | 0.16±0.54 |
| Mean change in MUAC Z score 1333,1330,1346) | 0.21±0.40 | 0.02 (-0.008,0.05) | 0.21±0.40 | 0.03 (-0.005,0.06) | 0.18±0.41 |
| Proportion stunted (1354,1356,1357) | 405 (29.9) | 1.16 (1.03,1.31) | 386 (28.5) | 1.11 (0.98,1.25) | 350 (25.8) |
| Proportion wasted (1354,1350,1360) | 86 (6.4) | 0.85 (0.64.1.12) | 102 (7.6) | 1.01 (0.77,1.31) | 102 (7.5) |
| Proportion underweight (1367,1370,1363) | 284 (20.8) | 1.08 (0.93,1.26) | 273 (19.9) | 1.04 (0.89,1.21) | 262 (19.2) |
| Proportion of study dropouts | 48 (3.2) | 1.00 (0.67,1.48) | 43 (2.9) | 0.89 (0.60,1.34) | 48 (3.2) |
| Proportion of mothers who report favorable child acceptability (n=1447,1453,1452) | 1199 (82.9) | 1.02 (0.99,1.06) | 1174 (80.8) | 1.00 (0.96,1.03) | 1177 (81.1) |
| Proportion of mothers who are willing to recommendation for use for other children | 1427 (98.3) | 1.00 (0.99,1.01) | 1426 (97.9) | 0.99 (0.98,1.00) | 1431 (98.4) |
| Proportion of mothers who report improvement in child's skin condition (n=1446,1453,1453) | 199 (13.8) | 1.05 (0.87,1.27) | 200 (13.8) | 1.05 (0.88,1.27) | 190 (13.1) |
| Proportion of mothers who report improvement in child's appetite (n=1446,1453,1453) | 609 (42.1) | 1.04 (0.96,1.14) | 606 (41.7) | 1.03 (0.95,1.13) | 587 (40.4) |
| Proportion of mothers who report improvement in child's activity level (n=1446,1453,1453) | 571 (39.5) | 1.00 (0.92,1.10) | 580 (39.9) | 1.02 (0.93,1.11) | 571 (39.3) |
| Proportion of mothers who report improvement in child's mood (n=1446,1453,1453) | 619 (42.8) | 1.03 (0.95,1.13) | 620 (42.7) | 1.03 (0.95,1.12) | 602 (41.4) |
| Proportion of mothers who report reduction in diarrhea severity (n=1446,1453,1453) | 1300 (89.9) | 1.00 (0.97,1.02) | 1315 (90.5) | 1.00 (0.98,1.03) | 1309 (90.1) |
1
Generalized estimating equations (GEE) with the log link, binomial distribution and exchangeable correlation matrix was used to estimate the relative risk and robust estimators of the variances were used to construct 95% confidence intervals.