Cholera is one of the leading causes of morbidity and mortality among children and adult in
developing countries. We will evaluate the effect of supplementation of zinc on reduction of
duration and severity of cholera. Since cholera is primarily a disease of older children and
adults, we intend to study the effects of zinc supplementation among children of 3 to 14
years of age, whose initial stool weight will be >4ml/kg/hour in 1st 6 hours and dark field
examination is positive. 90 subjects in each group hospitalized with cholera with diarrhea
for less than 24 hours will be selected. After inclusion in the study, informed consent will
be obtained from guardian explaining the full procedure in the hospital. The subjects will be
randomized to receive either zinc or placebo until diarrhea resolves. History of illness and
baseline information will be collected in the hospital through interview, which may take
duration of 10 minutes.After 6 hours of initial rehydration, fluid balance study will be
carried out on all subjects until diarrhea resolves. 1 ml (1/4 teaspoonful) of blood sample
will be taken to assess serum zinc level on admission after initial hydration and will be
repeated on the day of recovery. This procedure carries a small risk of infection if not done
under sanitary conditions; however, we will maintain proper sanitation, so there is no risk
in the procedures. There is no potential risk in this study.20mg elemental Zinc will be given
daily in 2 divided doses till cholera resolves. Both groups will receive syrup or tablet
Erythromycin 50mg/kg/24 in 4 divided doses for 3 days. Oral rehydration solution/intravenous
acetate fluid will be used for rehydration. Daily body weight will be taken and stool will be
sent for C/S until the day of recovery or 5 days. Zinc loss in stool will be seen in 20% of
random stool samples. Information obtained from history and the laboratory investigations of
subject will be kept strictly confidential and no one other than the investigators of this
study and the Ethics Committee of this Centre will/ has access to the information. The study
will benefit the patients as study physician will do close observation, examination and will
take care frequently, as research staff will monitor systematic progress and take necessary
action. Study micronutrient (zinc) is shown to have benefit in children in acute diarrhea. If
the results of the study is positive, it will benefit the patients in their treatment during
this study and thereafter. The data will be analyzed for clinical effects of zinc on
diarrhea.The study will help to improve the treatment strategy of cholera in children. The
study will use hospital records, which will be returned after completion of the study. Stool,
urine and 1 ml (1/4 teaspoonful) of venous blood will be taken to assess serum zinc level.
Phase:
Phase 3
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh