Table 4 Effect sizes in ANCOVA modelsa compared to standard care, with 90% CIs

From: Malnutrition enteropathy in Zambian and Zimbabwean children with severe acute malnutrition: A multi-arm randomized phase II trial

 

Colostrum n=25

N-acetyl glucosamine n = 24

Teduglutide n = 26

Budesonide n = 24

Composite score relative to Standard

Care, adjusted for core covariates

−0.58

(−1.4, 0.23) P = 0.24

−0.20

(−1.01, 0.60) P = 0.67

−0.89

(−1.69, −0.10) P = 0.07

−0.50

(−1.33, 0.33) P = 0.32

Plasma intestinal fatty acid binding protein (iFABP)

−152 (−1528, 1223) P = 0.86

608 (−749, 1966) P = 0.46

170 (−1156, 1497) P = 0.83

28 (−1354, 1409) P = 0.97

Plasma LBP (μg/mL)

−0.97 (−2.73, 0.79) P = 0.36

−1.38 (−3.10, 3.53) P = 0.19

−1.44 (−3.12, 0.24) P = 0.16

−1.44 (−3.20, 0.32) P = 0.18

Plasma soluble CD14 (μg/mL)

−0.10 (−0.46, 0.27) P = 0.65

0.26 (−0.11, 0.62) P = 0.25

0.19 (−0.16, 0.54) P = 0.38

0.08 (−0.29, 0.45) P = 0.73

Plasma soluble CD163 (ng/mL)

−212 (−543, 119) P = 0.29

−191 (−519, 138) P=0.34

−320 (−642, 3.0) P=0.10

−405 (−738, −73) P=0.05

Plasma C-Reactive Protein (mg/L)

−5.9 (−10.3, −1.4) P = 0.03

−4.8 (−9.2, −0.5) P = 0.07

−3.0 (−7.2, 1.2) P = 0.24

−5.2 (−9.6, −0.8) P = 0.05

Plasma GLP-2 (ng/mL)

1.4 (−0.2, 3.0) P = 0.14

0.92 (−0.6, 2.4) P = 0.31

0.69 (−0.8, 2.2) P = 0.44

0.007 (−1.5, 1.5) P = 0.99

Days with diarrhoea incidence rate ratio (IRR) (90%CIs) of the mean days of duration relative to standard care Zero-inflated negative binomialb

0.61 (0.29, 1.27) P = 0.27

0.11 (0.04, 0.33) P = 0.001

0.83 (0.42, 1.65) P = 0.66

0.96 (0.42, 2.21) P = 0.93

Days with fever IRR (90%CIs) Negative binomialc

2.35 (0.72, 7.69) P = 0.23

1.13 (0.40, 3.23) P = 0.85

1.64 (0.56, 4.81) P = 0.45

1.62 (0.57, 4.61) P = 0.45

Days with oedema IRR (children with oedematous SAM only) (90%CIs) Negative binomiald

1.27 (0.91, 1.78) P = 0.24

1.13 (0.73, 1.75) P = 0.63

1.20 (0.89, 1.62) P = 0.31

1.32 (0.93, 1.88) P = 0.19

Change in weight (kg) between baseline and day 15

0.27 (−0.35, 0.58) P = 0.14

0.05 (−0.25.0.36) P = 0.77

0.24 (−0.06, 0.54) P = 0.19

0.26 (−0.05, 0.57) P = 0.17

Change in height (cm) between baseline and day 15

0.15 (−0.28, 0.59) P = 0.55

0.06 (−0.38, 0.49) P = 0.83

0.16 (−0.26, 0.58) P = 0.53

−0.04 (−0.48, 0.40) P = 0.89

Change in MUAC (cm) between baseline and day 15

0.22 (−0.17, 0.60) P = 0.35

0.16 (−0.55, 0.22) P = 0.49

0.24 (−0.13, 0.62) P = 0.29

0.15 (−0.24, 0.55) P = 0.52

  1. Effect sizes are shown (with 90%CIs) for ANCOVA treatment effects, or incidence rate ratio (IRR) for negative binomial models; the precise models used for incidence rate data are indicated in italics. aComposite of faecal myeloperoxidase (MPO), neopterin (NEO), and alpha1-antitrypsin (AAT), calculated as 0.2xMPO + 2xAAT + NEO23. All statistical testing was 2-sided. aAdjusted for sex (male/female); oedema (yes/no); HIV status (yes/no); diarrhoea (yes/no); baseline WLZ scores (continuous); baseline biomarker value (continuous); and study site (Lusaka/Harare). MUAC, mid upper arm circumference. bAdjusted for sex (male/female) and HIV status (yes/no). cAdjusted for sex (male/female); HIV status (yes/no); baseline WLZ scores (continuous); and study site. dAdjusted for sex (male/female); baseline severity of oedema; HIV status (yes/no); baseline WLZ scores (continuous); and study site.
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