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Diarrhoea and vomiting caused by gastroenteritis in children under 5 years
There were no statistically significant differences between the two groups for the total duration
of the diarrhoeal episode, for the proportion of children with a diarrhoeal episode lasting more
than 10 days, for the total stool output or for the stool output in the first 24 hours after the start of
the intervention. The study found no statistically significant differences between study groups for
the volume vomited per day or for the rate of treatment failure (defined by the researchers as the
need for IVT after initial oral rehydration).
Another RCT (n = 90) 188 examined the effects of a single administration of 200 000 iu vitamin A
in children with shigella infection compared with the administration of a placebo. The patients
were children aged between 1 and 7 years who had presented to the outpatient department with
diarrhoeal stools. The methods of randomisation and allocation concealment were adequate
and a sample size power calculation was given. The patients and outcome assessors were blind
to treatment allocation. The outcomes measured in the trial were achievement of clinical and
bacteriological cure on study day 5. [EL = 1+]
Comparability of the groups at study entry was adequate and the proportion of patients randomised
but lost to follow-up was under 20%. ‘Clinical cure’ was defined as three or fewer formed stools
in a day without any visible blood or mucus and absence of fever and abdominal pain. The
authors found that 45% of children in the intervention group (19/42) and 20% in the control
group (8/41) were clinically cured by day 5. The difference was statistically significant (RR 2.32;
95% CI 1.15 to 4.69). No statistically significant difference in bacteriological cure (defined as the
continuous absence of shigella in both stool and rectal swab samples, from study day 3 onwards)
was found between the two groups,
A quasi-randomised controlled trial compared the therapeutic value of a single dose of
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100 000 iu oral vitamin A in outpatient children with acute diarrhoea against the administration
of placebo. The 120 children enrolled in the study were infants aged between 6 and 12 months
suffering from acute diarrhoea for less than 5 days. Those with malnutrition, dysentery or a
chronic condition were excluded. The method of randomisation was based on the patients’ file
numbers (odd or even). The patients and outcome assessors were blind to treatment allocation
and a sample size power calculation was given. [EL = 1−]
The groups were comparable at study entry. The proportion of patients randomised but lost to
follow-up was reported as under 20%. No statistically significant differences in the treatment
groups were reported for the mean total duration of diarrhoea or for persistent diarrhoea.
Evidence summary
Two RCTs located in Bangladesh [EL = 1+] and one quasi-RCT from Turkey [EL = 1−] were
identified for the effectiveness of vitamin A supplementation in the management of acute diarrhoea
in children. Meta-analysis could not be performed because of the variability of the studies. Data
from one of the RCTs showed no evidence of benefit in the duration of the diarrhoeal episode,
in the stool output, vomiting or number of treatment failures when comparing children that
received 200 000 iu of vitamin A with children receiving placebo. The other RCT suggested that
children with shigella infection supplemented with 200 000 iu of vitamin A were more likely to
have fewer formed stools with absence of fever and abdominal pain by day 5 than the placebo
children. The trial did not show a statistically significant difference between the two groups when
considering bacteriological cure. The quasi-RCT showed no statistically significant differences in
duration of diarrhoea or the onset of persistent diarrhoea between children receiving 100 000 iu
of vitamin A and children receiving placebo.
8.3.3 Glutamine
Evidence overview
A single-centre study undertaken in Turkey was identified. 178
The study was a quasi-randomised controlled trial in which a total of 159 infants were enrolled.
The participants were children aged 6–24 months with diarrhoea of less than 10 days’ duration.
Those children with chronic conditions, severe malnutrition, associated infectious diseases or
having been under antibiotic or antidiarrhoeal therapy were excluded from the trial. Eligible cases
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