Therapeutic Zinc in Childhood Pneumonia

October 2, 2009 updated by: Centre For International Health

Efficacy of Zinc as Adjuvant Therapy in the Treatment of Severe Pneumonia in Nepalese Children at the Kanti Children's Hospital

The aim of this study is to assess whether zinc given as adjuvant therapy to standard antibiotic treatment in children hospitalized for severe pneumonia reduces the duration of the severe illness and risk of treatment failure. A randomized double blind placebo controlled clinical trial will be conducted at the Kanti Hospital.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Nepal has an under-five mortality rate of 91/1000 live births. Pneumonia, one of the major killers accounts for the death of 25,000 - 35,000 Nepalese children every year. It is estimated that, on an average, of 1000 children <5 years of age that visit health facilities, 90 have pneumonia of which 4.2 have severe pneumonia. At the Kanti Children's Hospital, respiratory diseases are the most frequent reason for admission and the second most frequent cause of child death Zinc, an important micronutrient, is crucial for the normal function of the immune system as well as the integrity of the respiratory epithelium. Zinc deficiency is associated with an increased incidence and severity of diarrhea and respiratory tract infections. The preventive effect of zinc on diarrheal and respiratory illness has been well documented.

Early in an infection zinc is shifted into the liver from the plasma, bone, skin and intestines. For a child with initial low zinc levels, even relatively trivial infections may cause entry into the vicious cycle of reduced plasma zinc and increased infection severity. Administration of zinc during the acute illness may help in reducing the severity of illness.

The therapeutic effect of zinc in acute diarrhea has been well documented. In a study conducted at Bhaktapur, Nepal, in children 6 to 36 months of age, supplementation with zinc was found to be highly effective in the treatment of acute diarrhea.

The Kanti Children's Hospital in Kathmandu serves as a general and referral hospital for children from all parts of the country. Approximately 25% of all admissions to this hospital are due to pneumonia. Being the only well recognized children's hospital, there is always a constraint for available beds for children presenting with pneumonia. Zinc as an adjuvant to standard treatment of pneumonia with antimicrobials was found to hasten recovery from severe pneumonia in children less than 2 years of age in Bangladesh . If we were to conduct a similar study and prove that zinc does in fact help to shorten the duration of illness in children with severe pneumonia, it would go a long way in contributing to improve case management.

Study Type

Interventional

Enrollment (Actual)

641

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
      • Kathmandu, Nepal
        • Kanti Children Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged 2- 35 months with a history of cough (duration <14days) and difficult breathing of </= 72hours' duration, with lower chest indrawing.
  • Availability of informed consent.

Exclusion Criteria:

  • Children with severe wasting (<70% NCHS median weight for height)
  • Severe anemia (hemoglobin <7 gm/dl.)
  • Presence of heart disease with or without signs of cardiac failure.
  • Child with a chronic cough (lasting for ≥14 days)
  • Documented tuberculosis with ongoing treatment.
  • Associated other severe diseases that require special care or surgical intervention.
  • Children with concomitant diarrhea with some/severe dehydration
  • Children with a history of recurrent wheezing
  • Children enrolled in the study within the last 6 months of this visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Other Names:
  • Produced by Nutriset
  • Malaunay, France
Experimental: Zinc
Zinc sulphate 10 or 20 mg per day
Drug: Zinc (zinc sulphate)
Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months
Other Names:
  • Produced by Nutriset
  • Malaunay, France

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to cessation of severe pneumonia
Time Frame: Within 2 weeks after enrollment
Within 2 weeks after enrollment
The period starting from enrolment to the beginning of a 24-hour consecutive period of absence of lower chest indrawing, of hypoxia and of any danger signs.
Time Frame: Recovery from pneumonia within 2 weeks
Recovery from pneumonia within 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre For International Health

Collaborators

All India Institute of Medical Sciences, New Delhi
Statens Serum Institut
Institut de Recherche pour le Developpement
Tribhuvan University, Nepal
Society for Applied Studies

Investigators

  • Principal Investigator: Sudha Basnet, MD, Department of Child Health, Institute of Medicine, Tribhuwan University, Katmandu, Nepal
  • Study Director: Tor A Strand, MD, PhD, Centre For International Health
  • Study Chair: Halvor Sommerfelt, MD, PhD, Centre For International Health
  • Study Chair: Nita Bhandari, MBBS, PhD, Centre For International Health
  • Study Director: Prakash S Shrestha, MD, Child Health Research Project, Department of Child Health, Institute of Medicine, Maharajganj:
  • Study Chair: Ramesh K Adhikari, MD, Child Health Research Project, Department of Child Health, Institute of Medicine, Maharajganj:

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

November 10, 2005

First Submitted That Met QC Criteria

November 10, 2005

First Posted (Estimate)

November 11, 2005

Study Record Updates

Last Update Posted (Estimate)

October 6, 2009

Last Update Submitted That Met QC Criteria

October 2, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCO-CT-2004-003740-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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