Therapeutic Zinc in Childhood Pneumonia

NCT00252304 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 641

Last updated 2009-10-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Tribhuvan University, Nepal

    collaborator OTHER
  • Statens Serum Institut

    collaborator OTHER
  • All India Institute of Medical Sciences

    collaborator OTHER
  • Institut de Recherche pour le Developpement

    collaborator OTHER_GOV
  • Society for Applied Studies

    collaborator OTHER
  • Centre For International Health

    lead OTHER

Principal Investigators

  • Sudha Basnet, MD · Department of Child Health, Institute of Medicine, Tribhuwan University, Katmandu, Nepal

  • Tor A Strand, MD, PhD · Centre For International Health

  • Halvor Sommerfelt, MD, PhD · Centre For International Health

  • Nita Bhandari, MBBS, PhD · Centre For International Health

  • Prakash S Shrestha, MD · Child Health Research Project, Department of Child Health, Institute of Medicine, Maharajganj:

  • Ramesh K Adhikari, MD · Child Health Research Project, Department of Child Health, Institute of Medicine, Maharajganj:

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Nepal

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00252304 on ClinicalTrials.gov