Table.
Baseline characteristics of the intention-to-treat population
No-RUSF (n=908) | RUSF (n=897) | All (n=1805) | ||
---|---|---|---|---|
Male sex | 487 (54%) | 474 (53%) | 961 (53%) | |
Age at last birthday (years) | 36 (29–42; 5–71) | 36 (29–42; 6–77) | 36 (29–42; 5–77) | |
5–12 | 23 (3%) | 17 (2%) | 40 (2%) | |
13–17 | 18 (2%) | 14 (2%) | 32 (2%) | |
WHO HIV stage | ||||
1 | 152 (17%) | 148 (16%) | 300 (17%) | |
2 | 293 (32%) | 261 (29%) | 554 (31%) | |
3 | 338 (37%) | 353 (39%) | 691 (38%) | |
4 | 125 (14%) | 135 (15%) | 260 (14%) | |
In individuals aged ≥13 years | ||||
Weight* (kg)† (n=1760) | 52·7 (46·0–59·5) | 52·4 (46·5–59·2) | 52·5 (46·3–59·3) | |
BMI* (kg/m2)† (n=1758) | 19·3 (17·3–21·6) | 19·2 (17·4–21·4) | 19·3 (17·4–21·5) | |
BMI <18·5 kg/m2 | 354/880 (40·2%) | 343/878 (39%) | 697/1758 (40%) | |
MUAC* (cm; n=1764) | 24·0 (21·8–26·2) | 24·0 (22·0–26·0) | 24·0 (22·0–26·1) | |
Lean body mass (kg; n=1704) | 41·4 (37·4–46·9) | 41·5 (37·2–47·1) | 41·5 (37·3–47·0) | |
Fat mass (kg; n=1707) | 6·4 (3·5–12·3) | 6·8 (3·8–12·3) | 6·6 (3·7–12·3) | |
Basal metabolic rate (kcal/day; n=1674) | 1305 (1193–1438) | 1300 (1192–1446) | 1303 (1192–1441) | |
Grip strength (k; n=1772) | 24·2 (19·2–30·9) | 24·7 (19·4–31·1) | 24·5 (19·3–31·0) | |
Household food reported sufficient to feed | 627/898 (70%) | 610/890 (69%) | 1237/1788 (69%) | |
Household reported to grow own crops | 489/897 (55%) | 475/888 (53%) | 964/1785 (54%) | |
CD4 count* (cells per μL) | 34 (16–60) | 38 (16–64) | 37 (16–63) | |
0–24 | 344 (38%) | 312 (35%) | 656 (36%) | |
25–49 | 258 (28%) | 251 (28%) | 509 (28%) | |
HIV viral load (copies per mL; n=1804) | 244 110 (94 550–589 300) | 251 680 (95 680–626 610) | 249 770 (95 280–606 360) | |
≥100 000 | 675/908 (74%) | 659/896 (74%) | 1334/1804 (74%) | |
<1000‡ | 8/908 (<1%) | 6/896 (<1%) | 14/1804 (<1%) | |
Haemoglobin (g/L; n=1800) | 111 (96–126) | 112 (95–128) | 112 (96–127) | |
Supplementation prescribed at randomisation | ||||
RUSF§ | 1 (<1%) | 873 (97%) | 874 (48%) | |
RUTF | 38 (4%) | 24 (3%) | 62 (3%) | |
No supplementation | 869 (96%) | 0 | 869 (48%) |
Data are n (%), median (IQR; range), or median (IQR). RUSF=ready-to-use supplementary food. BMI=body-mass index. MUAC=mid-upper-arm-circumference. RUTF=ready-to-use therapeutic food.
Mean of screening and enrolment values. For eligibility, screening CD4 count had to be <100 cells per μL, so baseline values might be more than 100 cells per μL depending on the count at enrolment.
Among children aged younger than 13 years, median (IQR) weight-for-age, height-for-age, and BMI-for-age Z scores were −2·6 (−3·4 to −1·5), −1·9 (−2·6 to −1·3), and −1·9 (−2·8 to −1·1), respectively.
Potentially indicating undisclosed previous antiretroviral therapy: median CD4 cell count of 76 cells per μL in these participants.
One participant with BMI 17·8 kg/m2 randomly assigned to no-RUSF started RUSF on day 0 (protocol deviation).