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Table 2 Compliance, safety, and growth

From: Ready-to-use therapeutic food with elevated n-3 polyunsaturated fatty acid content, with or without fish oil, to treat severe acute malnutrition: a randomized controlled trial

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
  1. 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.
  2. 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.