Clinical Trial: Zinc Supplementation in Cholera Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clinical Trial of Zinc Supplementation in Cholera Patients
Brief Summary: 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 t
Detailed Summary:
Study design:
A double blind randomized clinical trial using zinc and placebo.
Randomization:
Patients will be randomized to one of two groups, A or B. Block randomization will be done using block length of 6. Group A will receive Zinc+ Erythromycin and Group B: will receive Placebo+Erythromycin
Dose of Erythromycin
Syrup/tab Erythromycin 50mg/kg/24 hours in 4 divided doses for 3 days.
Dose of zinc:
Zinc acetate will be given at 10mg twice daily (10mgx2=20mg elemental zinc) until cholera resolves (the time of passage of last unformed stool or first formed stool followed by 24 hours without any diarrheal stool).
Composition of the syrup:
For both groups, the bulk of the base syrup will be consist of the same chemicals; in addition to this, group A will have the treatment substance (i.e. elemental zinc 20 mg/day)
Syrup A: Quantity per 5 ml
Zinc Acetate 10 mg elemental zinc
Syrup B: Base substance
Base Substance:
Ascorbic acid 30 mg Glycerin USP 1.2 ml Propylene glycol USP 0.75 ml Sorbitol 70% BP 2.0 ml Methyl Paraben USFN 3.5 mg Polysorate-80 50 mg (Tween –80) BPC Lemon oil PH grade 0.0125 ml Caramel Brown colour 1 mg Purified water 0.75 ml
Clinical procedure in the hospital:
<Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Current Primary Outcome:
- Reduction in duration of diarrhoea
- Reeudction in total stool volume
Original Primary Outcome: Same as current
Current Secondary Outcome: Serum Zinc status
Original Secondary Outcome: Same as current
Information By: International Centre for Diarrhoeal Disease Research, Bangladesh
Dates:
Date Received: September 25, 2005
Date Started: November 2000
Date Completion: July 2002
Last Updated: October 19, 2005
Last Verified: September 2005
