Zinc Supplementation in Cholera Patients

NCT00226616 | Completed Phase 3

• 1 other identifier: 99-022
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Cholera

Keywords

Zinc; cholera; children; Bangladesh

Outcome Measures

Primary Outcomes (2)

• Reduction in duration of diarrhoea

• Reeudction in total stool volume

Secondary Outcomes (1)

• Serum Zinc status

Interventions

Zinc DRUG

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 3-14 years hospitalized at ICDDR, B presenting with cholera within 24 hours of onset.
• Stool output more than 4ml/kg/hour within the first 6 hours of observation period.
• Positive dark field examination

You may not qualify if:

• Unable to rehydrate within 6 hours
• Negative dark field examination
• Systemic illness requiring immediate administration of antibiotics.
• Received antibiotics in the 24 hours prior to hospitalization
• Patients presenting with bloody mucoid diarrhea
• Unconscious or medical emergencies

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Thrasher Research Fund: collaborator
• World Bank: collaborator

Study Sites (2)

ICDDR,B, Dhaka hospital

Dhaka, 1000, Bangladesh

Location

S.k.Roy

Dhaka, 1000, Bangladesh

Location

Related Publications (1)

• Roy SK, Hossain MJ, Khatun W, Chakraborty B, Chowdhury S, Begum A, Mah-e-Muneer S, Shafique S, Khanam M, Chowdhury R. Zinc supplementation in children with cholera in Bangladesh: randomised controlled trial. BMJ. 2008 Feb 2;336(7638):266-8. doi: 10.1136/bmj.39416.646250.AE. Epub 2008 Jan 8.

  PMID: 18184631 DERIVED

MeSH Terms

Conditions

Cholera

Interventions

Zinc

Condition Hierarchy (Ancestors)

Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Swapan K Roy, MBBS,MSc,Phd

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 25, 2005
• First Posted: September 27, 2005
• Study Start: November 1, 2000
• Study Completion: July 1, 2002
• Last Updated: October 20, 2005

Record last verified: 2005-09

Locations

BA (2)