Placebo | VAS | p Value | |
---|---|---|---|
Adverse event reported within 1 week of supplementation | 16/5380 (0.3%) | 10/5648 (0.2%) | 0.2 |
(95% CI 0.2 to 0.5) | (95% CI 0.1 to 0.3) | ||
Distribution of adverse events | |||
Loose motion | 8/16 (50%) | 7/10 (75%) | |
(95% CI 23 to 77) | (95% CI 39 to 100) | ||
Vomiting | 2/16 (12.5%) | 1/10 (10.0%) | |
(95% CI 0 to 30) | (95% CI 0 to 31) | ||
Bulging fontanel | 1/16 (6%) | 1/10 (10%) | |
(95% CI 0 to 19) | (95% CI 0 to 31) | ||
Unconsciousness | 1/16 (6%) | 0/10 (0%) | |
(95% CI 0 to 19) | (95% CI – –) | ||
Seizures | 1/16 (6%) | 1/10 (10%) | |
(95% CI 0 to 19) | (95% CI 0 to 31) | ||
Fever | 3/16 (19%) | 0/10 (0%) | |
(95% CI 0 to 40) | (95% CI – –) | ||
Hospitalisation during first 6 months of life | 185/5380 (3.4%) | 185/5648 (3.3%) | 0.6 |
(95% CI 2.9 to 3.9) | (95% CI 2.8 to 3.7) |
Data are n or n (%).