Diarrhea Clinical Trial
Official title:
Establishing the Optimal Dose of Therapeutic Zinc Supplementation for the Treatment of Acute Diarrhea in Under Five Children - a Dose Response Trial in a South Asian and a Sub-Saharan African Setting
Diarrhoea continues to be a major cause of child deaths. Current treatment of acute watery
diarrhoea includes oral rehydration solution (ORS), zinc and continued feeding. The use of
zinc is based on a number of studies that showed that zinc reduces the duration and severity
of diarrhoea. The recommended dose of zinc in 6-59 month old children is 20mg/day for 10-14
days. This dose is associated with an increased risk of vomiting. No dosing studies are
available to determine the optimal dose of zinc, which while maintaining the benefits also
has a low risk of vomiting.
The investigators will conduct a double-blind randomized controlled trial of three doses of
zinc (20mg/day, 10mg/day and 5mg/day) in two settings - one in Sub-Saharan Africa and the
other in South Asia. The study population will be 4500 children with diarrhoea of less than
72 hours duration who are aged 6-59 months. They will be recruited from outpatient health
facilities. All enrolled children will receive ORS and continued feeding as recommended by
the World Health Organization. Those allocated to the standard zinc dose will receive an oral
dispersible tablet with 20mg zinc daily for 14 days. Those allocated to lower dose zinc will
receive identical tablets with either 10mg or 5mg zinc daily for 14 days. Enrolled children
will be followed by until recovery from diarrhoea or 15 days after enrolment, whichever is
later. In addition, study children will be assessed again at thirty (30), forty-five (45),
and sixty (60) days to estimate impact on post illness outcomes. Primary outcomes will be
mean duration of diarrhoea, proportion of episodes that last longer than 5 days, mean number
of stools and proportion of children with vomiting.
n/a
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