Introduction
Methods
Study design
Study setting
Anthropometry
Outcomes and exposures
Statistical analysis
Results
n (%) or mean (± SD) | |
---|---|
Study site, n (%) | |
India | 2250 (50.0) |
Tanzania | 2250 (50.0) |
Maternal Characteristics | |
Age (years) | 5.0 (± 26.8) |
Education (years) | 4.1 (± 7.2) |
Education > 7 years, n (%) | 1990 (44.8) |
Household Characteristics | |
Household wealth index above median, n (%) | 2270 (50.5) |
Improved water, n (%) | 4455 (99.2) |
Improved sanitation, n (%) | 4463 (99.4) |
Child Characteristics | |
Age in months at randomization | 14.9 (± 23.0) |
Age group at randomization | |
6 < 12 months, n (%) | 1256 (27.9) |
12 to < 24 months, n (%) | 1477 (32.8) |
24 to < 60 months, n (%) | 1767 (39.3) |
Male, n (%) | 2345 (52.1) |
Breastfeeding on day before enrolment, n (%) | 2586 (57.6) |
Rotavirus vaccination, n (%) | 2238 (49.7) |
Duration of diarrhoea before enrolment | |
≤ 24 h, n (%) | 165 (3.7) |
25 to 48 h, n (%) | 3714 (82.5) |
49 to < 72 h, n (%) | 621 (13.8) |
Number of loose or watery stools the child passed in previous 24 h | 5.7 (± 2.1) |
Dysentery, n (%) | 167 (3.7) |
Some dehydration, n (%) | 56 (1.2) |
Axillary temperature > 38 °C, n (%) | 122 (2.7) |
Observed respiratory rate > 40 breaths/min, n (%) | 255 (5.7) |
Cough or difficulty breathing, n (%) | 1267 (28.2) |
Previous use of antibiotics, n (%) | 96 (2.1) |
Length/height-for-age z-score | 1.2 (± -1.3) |
Weight-for-age z-score | 1.1 (± -1.2) |
Weight-for-length/height z-score | 1.0 (± -0.7) |
Mid–upper-arm circumference for age z score | 1.0 (± -0.8) |
Underweight at enrolment, n (%) | 1034 (23.0) |
Stunted at enrolment, n (%) | 1188 (26.4) |
Wasted at enrolment run, n (%) | 407 (9.0) |
Malnutrition status at enrolment | |
Severe acute malnutrition, n (%) | 47 (1.0) |
Moderate acute malnutrition, n (%) | 593 (13.2) |
Not malnourished, n (%) | 3860 (85.8) |
Plasma zinc concentration at enrolment — µg/dl | 73.5 (24.9) |
Plasma zinc concentration at enrolment < 65 µg/dl, n (%) | 492 (37.6) |
Univariate | Multivariate | |||
---|---|---|---|---|
Variables | Prevalence Ratio | P value | Prevalence Ratio | P value |
Country | ||||
India | Ref | Ref | ||
Tanzania | 0.41 (0.35, 0.49) | < 0.001 | 0.37 (0.30, 0.44) | < 0.001 |
Maternal age > 25 years | ||||
No | Ref | Ref | ||
Yes | 0.82 (0.70, 0.95) | 0.008 | 0.92 (0.80, 1.07) | 0.30 |
Maternal education > 7 years | ||||
No | Ref | |||
Yes | 0.94 (0.80, 1.09) | 0.39 | ||
Child age, month | ||||
6- < 12 | Ref | Ref | ||
12 to < 24 | 0.85 (0.71, 1.02 | 0.07 | 0.83 (0.70, 0.99) | 0.04 |
24 to < 60 | 0.57 (0.48, 0.69) | < 0.001 | 0.46 (0.38, 0.56) | < 0.001 |
Child sex | ||||
Female | Ref | |||
Male | 0.96 (0.83, 1.12) | 0.61 | ||
Household wealth index above median | ||||
No | Ref | Ref | ||
Yes | 0.78 (0.67, 0.91) | 0.002 | 0.79 (0.68, 0.92) | 0.002 |
Breast-feeding before enrolment | ||||
No | Ref | |||
Yes | 1.33 (1.14, 1.55) | < 0.001 | ||
Duration of diarrhoea before enrolment | ||||
< = 24 h | Ref | Ref | ||
25 to 48 h | 0.86 (0.60, 1.23) | 0.40 | 0.79 (0.55, 1.13) | 0.20 |
49 to < 72 h | 0.67 (0.44, 1.02) | 0.06 | 0.93 (0.60, 1.42) | 0.72 |
Dysentery | ||||
No | Ref | |||
Yes | 0.81 (0.52, 1.26) | 0.35 | ||
Dehydration | ||||
No | Ref | |||
Yes | 1.35 (0.76, 2.37) | 0.30 | ||
Axillary temperature > 38 °C | ||||
No | Ref | |||
Yes | 0.86 (0.52, 1.41) | 0.55 | ||
Observed respiratory rate > 40 breaths/min | ||||
No | Ref | Ref | ||
Yes | 0.61 (0.41, 0.93) | 0.02 | 0.72 (0.47, 1.10) | 0.13 |
Cough or difficulty breathing | ||||
No | Ref | Ref | ||
Yes | 1.29 (1.10, 1.51) | 0.001 | 1.04 (0.89, 1.22) | 0.60 |
Previous use of antibiotic agent | ||||
No | Ref | |||
Yes | 1.26 (0.80, 1.98) | 0.32 | ||
Plasma zinc concentration at enrolment < 65 µg/dl | ||||
No | Ref | Ref | ||
Yes | 0.79 (0.59, 1.04) | 0.09 | 1.13 (0.86, 1.49) | 0.38 |
Improved water | ||||
No | Ref | |||
Yes | 0.66 (0.34, 1.29) | 0.23 | ||
Improved sanitation | ||||
No | Ref | |||
Yes | 1.24 (0.43, 3.64) | 0.69 |
Univariate | Multivariate | |||
---|---|---|---|---|
Variables | Risk Ratio | P value | Risk Ratio | P value |
Country | ||||
India | Ref | Ref | ||
Tanzania | 0.62 (0.40, 0.94) | 0.02 | 0.67 (0.45, 1.01) | 0.06 |
Maternal age > 25 years | ||||
No | Ref | |||
Yes | 1.14 (0.75, 1.73)) | 0.55 | ||
Maternal education > 7 years | ||||
No | Ref | |||
Yes | 0.99 (0.65, 1.50 | 0.95 | ||
Child age, month | ||||
6- < 12 | Ref | Ref | ||
12 to < 24 | 1.86 (1.07, 3.21) | 0.03 | 1.24 (0.74, 2.07) | 0.41 |
24 to < 60 | 0.97 (0.54, 1.74) | 0.92 | 0.48 (0.27, 0.85) | 0.01 |
Child sex | ||||
Female | Ref | |||
Male | 1.01 (0.66, 1.53) | 0.97 | ||
Breast-feeding before enrolment | ||||
No | Ref | |||
Yes | 1.29 (0.84, 1.98) | 0.24 | ||
Household wealth index above median | ||||
No | Ref | |||
Yes | 1.02 (0.67, 1.55) | 0.92 | ||
Duration of diarrhoea before enrolment | ||||
< = 24 h | Ref | |||
25 to 48 h | 0.79 (0.29, 2.13) | 0.64 | ||
49 to < 72 h | 0.71 (0.23, 2.19) | 0.55 | ||
Dysentery | ||||
No | Ref | |||
Yes | 0.89 (0.28, 2.78) | 0.84 | ||
Dehydration | ||||
No | Ref | |||
Yes | 1.04 (0.15, 7.30) | 0.97 | ||
Axillary temperature > 38 °C | ||||
No | Ref | |||
Yes | 1.62 (0.61, 4.34) | 0.33 | ||
Observed respiratory rate > 40 breaths/min | ||||
No | Ref | |||
Yes | 0.77 (0.28, 2.07) | 0.60 | ||
Cough or difficulty breathing | ||||
No | Ref | |||
Yes | 1.00 (0.63, 1.59) | 1.00 | ||
Previous use of antibiotic agent | ||||
No | Ref | |||
Yes | Non-estimable due to zero | |||
Plasma zinc concentration at enrolment < 65 µg/dl | ||||
No | Ref | |||
Yes | 0.65 (0.27, 1.56) | 0.34 | ||
Weight-for-Height z-score at enrolment | 0.07 (0.04, 0.11) | < 0.001 | 0.07 (0.04, 0.11) | < 0.001 |
Duration of episode, days | ||||
< 3 | Ref | |||
3–5 | 1.04 (0.67, 1.60) | 0.87 | ||
> 5 | 0.88 (0.35, 2.19) | 0.79 | ||
Number of loose or watery stools after enrolment* | ||||
< 7 | Ref | |||
7–9 | 1.10 (0.57, 2.14) | 0.78 | ||
10–12 | 0.95 (0.55, 1.65) | 0.86 | ||
> 12 | 0.83 (0.48, 1.40) | 0.48 | ||
Dose of Zinc intervention | ||||
20 mg | Ref | |||
10 mg | 1.31 (0.81, 2.12) | 0.27 | ||
5 mg | 0.73 (0.42, 1.28) | 0.27 | ||
Improved water | ||||
No | Ref | |||
Yes | 0.64 (0.09, 4.40) | 0.62 |