Table 2.
Compliance, safety, and growth
| Compliance | S-RUTF | F-RUTF | FFO-RUTF | P |
|---|---|---|---|---|
| % RUTF to d28 | 89 (62 to 102) | 95 (79 to 102) | 95 (88 to 103) | 0.42 |
| % RUTF to d84 | 90 (80 to 101) | 96 (67 to 100) | 92 (76 to 100) | 0.98 |
| % Capsules to d28 | – | – | 90 (71 to 99) | – |
| % Capsules to d84 | – | – | 88 (79 to 95) | – |
| Safety | ||||
| Deaths | 1 | 3 | 2 | 0.86 |
| Other serious adverse events | 5 | 0 | 4 | – |
| Total death or serious adverse event | 6 | 3 | 6 | 0.63 |
| Total illness episodes | 50 | 47 | 54 | 0.27 |
| Common illness syndromes | ||||
| Upper respiratory tract infection | 7 | 19 | 16 | 0.08 |
| Lower respiratory tract infection | 3 | 2 | 4 | 0.90 |
| Rash | 10 | 5 | 13 | 0.16 |
| Diarrhea | 7 | 7 | 4 | 0.75 |
| Vomiting | 2 | 6 | 7 | 0.20 |
| Growth | ||||
| Mid-upper arm circumference change | ||||
| Enrolment to d28 (mm/day x103) | 46 (21 to 72) | 52 (24 to 68) | 54 (36 to 75) | 0.53 |
| Enrolment to d84 (mm/day x103) | 21 (17 to 39) | 21 (17 to 29) | 21 (18 to 29) | 0.48 |
| Weight-for-height/length change | ||||
| Enrolment to d28 (z score/day x103) | 57 (21 to 80) | 60 (47 to 84) | 58 (34 to 88) | 0.23 |
| Enrolment to d84 (z score/day x103) | 20 (14 to 35) | 21 (14 to 33) | 23 (15 to 27) | 0.96 |
| Height/length-for-age change | ||||
| Enrolment to d28 (z score/day x103) | −11.9 (−22.9 to −2.5) | −8.0 (−20.9 to −1.0) | −10.4 (−15.7 to 2.9) | 0.75 |
| Enrolment to d84 (z score/day x103) | 3.0 (−4.5 to 5.6) | 4.0 (0.4 to 5.8) | 0.2 (−2.3 to 4.6) | 0.40 |
| Head circumference-for-age change | ||||
| Enrolment to d28 (z score/day x103) | 10.1 (1.8 to 17.1) | 13.2 (5.8 to 17.0) | 6.1 (−6.4 to 20.4) | 0.71 |
| Enrolment to d84 (z score/day x103) | 8.1 (0.6 to 9.8) | 5.8 (3.9 to 8.4) | 7.4 (1.2 to 9.3) | 0.96 |
Data are absolute numbers or median (inter-quartile range) unless otherwise specified. Total illness episodes are compared by χ2 test. Individual illness syndromes, deaths, and deaths/serious adverse events are by Fishers Exact test. Compliance and growth by ANOVA.
S-RUTF, Trial arm receiving standard-formulation RUTF without fish oil capsules; FFO-RUTF, Trial arm receiving flax seed oil-containing RUTF and fish oil capsules; F-RUTF, Trial arm receiving flax seed oil-containing RUTF without fish oil capsules.