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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.