Therapeutic Zinc in Childhood Pneumonia

This study has been completed.
Sponsor:
Collaborators:
Tribhuvan University, Nepal
Statens Serum Institut
All India Institute of Medical Sciences, New Delhi
Institut de Recherche pour le Developpement
Society for Applied Studies
Information provided by:
Centre For International Health
ClinicalTrials.gov Identifier:
NCT00252304
First received: November 10, 2005
Last updated: October 2, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Pneumonia
Drug: Zinc (zinc sulphate)
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Zinc as Adjuvant Therapy in the Treatment of Severe Pneumonia in Nepalese Children at the Kanti Children's Hospital

Resource links provided by NLM:


Further study details as provided by Centre For International Health:

Primary Outcome Measures:
  • Time to cessation of severe pneumonia [ Time Frame: Within 2 weeks after enrollment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 641
Study Start Date: January 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Other Names:
  • Produced by Nutriset
  • Malaunay, France

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.

  Eligibility

Ages Eligible for Study:   2 Months to 35 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252304

Locations
Nepal
Kanti Children Hospital
Kathmandu, Nepal
Sponsors and Collaborators
Centre For International Health
Tribhuvan University, Nepal
Statens Serum Institut
All India Institute of Medical Sciences, New Delhi
Institut de Recherche pour le Developpement
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:
  More Information

Publications:
Nepal Ministry of Health, Department of Health Services Annual Report 2000- 2001, Kathmandu
Beisel WR. Zinc metabolism in infection. In: Brewer GJ, Prasad AS, eds. Zinc metabolism: current aspects in health and disease. New York: Alan R Liss, 1977: 973-977

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tor A Strand/ Researcher, University of Bergen
ClinicalTrials.gov Identifier: NCT00252304     History of Changes
Other Study ID Numbers: INCO-CT-2004-003740-2
Study First Received: November 10, 2005
Last Updated: October 2, 2009
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Centre For International Health:
Child, severe pneumonia, Zinc, Nepal, therapeutic

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Zinc
Zinc Sulfate
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Astringents
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014