Table 2. Outcomes of 335 children with at least one home visit by study cohort and treatment arm.
| Characteristic | HIV-infected children | HIV-uninfected children born to HIV-infected mothers | HIV-uninfected children born to HIV-uninfected mothers | |||||||||
| Treatment Group | P | Treatment Group | P | Treatment Group | P | |||||||
| Vitamin A (n = 8) | Vitamin A+zinc (n = 9) | Multiple micronutrients (n = 11) | Vitamin A (n = 49) | Vitamin A+zinc (n = 47) | Multiple micronutrients (n = 46) | Vitamin A (n = 56) | Vitamin A+zinc (n = 57) | Multiple micronutrients (n = 52) | ||||
| Primary outcome | ||||||||||||
| Percentage of days with diarrhea per child | 3.4 (0.8–9.4) | 7.1 (2.4–12.3) | 5.9 (1.5–16.1) | 0.668 | 2.3 (0.7–4.0) | 2.5 (0.8–4.4) | 2.2 (0.8–5.5) | 0.852 | 2.4 (0.9–5.0) | 1.8 (0.5–5.1) | 2.7 (0.5–4.6) | 0.857 |
| Secondary outcomes-diarrhea | ||||||||||||
| Children who ever had diarrhea, n (%) | 7 (87.5) | 8 (88.9) | 9 (81.8) | 0.891 | 44 (89.8) | 39 (83.0) | 40 (87.0) | 0.616 | 47 (83.9) | 45 (78.9) | 40 (76.9) | 0.642 |
| Children who ever had blood in stools, n (%) | 2 (25.0) | 3 (33.3) | 6 (54.5) | 0.388 | 11 (22.4) | 12 (25.5) | 11 (23.9) | 0.939 | 13 (23.2) | 11 (19.3) | 10 (19.2) | 0.838 |
| Diarrhea episodes per child | 2 (1–7) | 3 (2–7) | 3 (2–5) | 0.790 | 2 (1–5) | 2 (1–4) | 2 (1–4) | 0.956 | 3 (1–6) | 2 (1–4) | 3(1–5) | 0.719 |
| Duration of diarrhea episode, days | 3.0 (2.3–5.6) | 4.4 (3.1–5.5) | 6.3 (2.8–7.8) | 0.260 | 3.0 (2.5–4.0) | 4.0 (2.5–5.3) | 3.9 (2.4–5.1) | 0.353 | 3.2 (2.5–5.0) | 3.9 (2.8–4.9) | 4.0 (2.0–4.7) | 0.515 |
| Children with diarrhea episodes ≥14 d, n (%) | 0 | 3 (33.3) | 3 (27.3) | 0.206 | 3 (6.1) | 3 (6.4) | 6 (13.0) | 0.395 | 2 (3.6) | 5 (8.8) | 3 (5.8) | 0.508 |
| Children with >5 stools/day on worst day of diarrhea episode* | 3/7 (42.9) | 4/8 (50.0) | 5/9 (55.6) | 0.881 | 18/44 (40.9) | 20/39 (51.3) | 15/40 (37.5) | 0.436 | 19/47 (40.4) | 19/45 (42.2) | 23/40 (57.5) | 0.226 |
| Children who visited clinic for diarrhea, n (%) | 3 (37.5) | 6 (66.7) | 9 (81.8) | 0.136 | 28 (57.1) | 19 (40.4) | 23 (50.0) | 0.260 | 30 (53.6) | 23 (40.4) | 20 (38.5) | 0.220 |
| Secondary outcomes–respiratory illness | ||||||||||||
| Percentage of weeks with upper respiratory symptoms | 12.4 (2.0–36.2) | 29.0 (10.1–50.0) | 23.7 (20.2–33.3) | 0.222 | 13.1 (7.8–24.7) | 14.0 (6.2–23.0) | 14.3 (7.8–22.4) | 0.940 | 16.6 (9.0–22.9) | 15.8 (9.0–24.2) | 14.2 (7.8–25.4) | 0.766 |
| Children who ever had pneumonia by maternal report, n (%) | 3 (37.5) | 4 (44.4) | 6 (54.5) | 0.755 | 11 (22.4) | 14 (29.8) | 5 (10.9) | 0.079 | 9 (16.1) | 12 (21.1) | 10 (19.2) | 0.791 |
| Children who ever had pneumonia confirmed by measured respiratory rate, n (%) | 3 (37.5) | 1 (11.1) | 4 (36.4) | 0.371 | 8 (16.3) | 9 (19.1) | 2 (4.3) | 0.084 | 6 (10.7) | 10 (17.5) | 5 (9.6) | 0.397 |
| Other secondary outcomes | ||||||||||||
| Died during study, N, (%) | 2 (25.0) | 4 (44.4) | 2 (18.2) | 0.418 | 0 | 1 (2.1) | 1 (2.2) | 0.586 | 1 (1.8) | 1 (1.8) | 0 | 0.628 |
| Admitted to hospital for any reason during study | 0 | 2 (22.2) | 4 (36.4) | 0.162 | 1 (2.0) | 4 (8.5) | 4 (8.7) | 0.312 | 3 (5.4) | 4 (7.0) | 3 (5.8) | 0.929 |
Values are median (25th–75th centiles) or n (%). P values are for the overall group comparison using the Kruskall-Wallis test or 2 x 3 χ2 test.
*
Denominator is number of study children who ever had diarrhea.