Zinc in Childhood Pneumonia - Article Orazinc; Verazinc; Zinc 15; Zinc Gluconate; Zinc Sulfate; Zincate
Clinical Trial: Zinc in Childhood Pneumonia
This study is not yet open for patient recruitment.
Verified by Centre For International Health November 2005
|Pneumonia || Drug: Zinc (zinc sulphate) ||Phase II |
MedlinePlus related topics: Pneumonia
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Expected Total Enrollment: 900
Study start: December 2005; Expected completion: March 2008
Last follow-up: December 2007; Data entry closure: January 2008
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.
• 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.
• 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.
Location and Contact Information
Nita Bhandari, MBBS, PhD + 47 55 974980 firstname.lastname@example.org
Kanti Children Hospital, Kathmandu, Nepal
Renu Prasai, MBBS DCH +977 1 4370158 email@example.com
Sudha Basnet, MD, Principal Investigator
Prakash S Shresta, MD, Principal Investigator
Maria Mathisen, MD, Sub-Investigator
Palle Valentiner-Branth, MD, PhD, Sub-Investigator
Sudha Basnet, MD, Principal Investigator, Department of Child Health, Institute of Medicine, Tribhuwan University, Katmandu, Nepal
Tor A Strand, MD, PhD, Study Director, Centre For International Health
Halvor Sommerfelt, MD, PhD, Study Chair, Centre For International Health
Nita Bhandari, MBBS, PhD, MNAMS, Study Chair, Centre For International Health
Prakash S Shrestha, MD, Study Director, Child Health Research Project, Department of Child Health, Institute of Medicine, Maharajganj:
Ramesh K Adhikari, MD, Study Chair, Child Health Research Project, Department of Child Health, Institute of Medicine, Maharajganj:
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Last Updated: December 8, 2005
Record first received: November 10, 2005
ClinicalTrials.gov Identifier: NCT00252304
Health Authority: Norway: The National Committees for Research Ethics in Norway
ClinicalTrials.gov processed this record on 2006-01-10