|
Safety and compliance
| | | |
|
Deaths
|
0
|
1
|
0.32
|
|
Hospitalizationsa
|
0
|
2
|
0.15
|
|
Total adverse events
|
35
|
27
|
0.53
|
|
Acute watery diarrhea
|
7
|
8
|
0.53
|
|
Bloody diarrhea
|
0
|
2
|
0.32
|
|
Chronic diarrhea
|
1
|
1
|
1.00
|
|
μgastroenteritis (with vomiting)
|
5
|
1
|
0.15
|
|
μgiardiasis
|
6
|
6
|
1.00
|
|
Oral candidiasis
|
3
|
0
|
0.08
|
|
Upper respiratory tract infection
|
3
|
5
|
0.64
|
|
Lower respiratory tract infection
|
3
|
1
|
0.30
|
|
Tuberculosis
|
1
|
1
|
1.00
|
|
Malaria/non-specific febrile illness
|
4
|
3
|
0.43
|
|
Rash
|
2
|
2
|
1.00
|
|
Total gastrointestinal adverse events
|
23
|
16
|
0.27
|
|
Total diarrheal adverse events
|
8
|
11
|
0.65
|
|
Unable to dose-escalate at day 7
|
1 (5)
|
7 (32)
|
0.05
|
|
Compliance (%)
|
93 (71 to 98)
|
97 (82 to 99)
|
0.44
|
|
Anthropometry and recovery
| | | |
|
Recovery: nutritionally cured at day 56
|
13
|
12
|
1.00
|
|
Recovery: RUTF-free days at day 56
|
9 (0 to 21)
|
9.5 (0 to 21)
|
0.94
|
|
Nutritional edema
|
Baseline
|
15/22 (68)
|
17/22 (77)
|
0.72
|
|
Day 28
|
7/22 (32)
|
6/22 (27)
|
1.00
|
|
Day 56b
|
3/20 (15)
|
2/19 (11)
|
1.00
|
|
MUAC (mm)
|
Baseline
|
12.9 (11.2 to 14.4)
|
12.7 (11.2 to 13.8)
|
0.56
|
|
Day 28
|
13.7 (11.8 to 14.7)
|
13.2 (12.2 to 14.6)
|
0.82
|
|
Day 56
|
13.9 (12.5 to 14.8)
|
13.6 (13.0 to 15.1)
|
0.59
|
|
MUAC growth rate (mm/day)
|
To day 28
|
0.23 (0.06 to 0.37)
|
0.31 (0.18 to 0.61)
|
0.15
|
|
To day 56
|
0.12 (0.08 to 0.21)
|
0.23 (0.14 to 0.33)
|
0.01
|
|
Height growth rate (mm/day) to day 56
|
0.31 (0.19 to 0.38)
|
0.32 (0.21 to 0.38)
|
0.94
|
|
Height-for-age z-score
|
Baseline
|
-3.13 (-3.83 to -2.71)
|
-3.73 (-4.60 to -2.71)
|
0.29
|
|
Day 28
|
-3.17 (-4.04 to -2.61)
|
-3.70 (-4.20 to -2.73)
|
0.42
|
|
Day56
|
-3.24 (-4.10 to -2.68)
|
-3.46 (-4.14 to -2.68)
|
0.79
|
