Clinical trial NCT00252304: Therapeutic Zinc in Childhood Pneumonia
Official title: Efficacy of Zinc as Adjuvant Therapy in the Treatment of Severe Pneumonia in Nepalese Children at the Kanti Children's Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pneumonia
Keywords: Child, severe pneumonia, Zinc, Nepal, therapeutic
Lead sponsor: Centre For International Health
Sponsor class: OTHER
Collaborators: name: Tribhuvan University, Nepal
name: Statens Serum Institut
name: All India Institute of Medical Sciences
name: Institut de Recherche pour le Developpement
name: Society for Applied Studies
First posted: 2005-11-11
Enrollment: 641
Sex: ALL
Minimum age (years): 2
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Time to cessation of severe pneumonia
timeFrame: Within 2 weeks after enrollment
measure: 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.
timeFrame: Recovery from pneumonia within 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Kanti Children Hospital
Study officials:
affiliation: Department of Child Health, Institute of Medicine, Tribhuwan University, Katmandu, Nepal
name: Sudha Basnet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre For International Health
name: Tor A Strand, MD, PhD
role: STUDY_DIRECTOR
affiliation: Centre For International Health
name: Halvor Sommerfelt, MD, PhD
role: STUDY_CHAIR
affiliation: Centre For International Health
name: Nita Bhandari, MBBS, PhD
role: STUDY_CHAIR
affiliation: Child Health Research Project, Department of Child Health, Institute of Medicine, Maharajganj:
name: Prakash S Shrestha, MD
role: STUDY_DIRECTOR
affiliation: Child Health Research Project, Department of Child Health, Institute of Medicine, Maharajganj:
name: Ramesh K Adhikari, MD
role: STUDY_CHAIR
References:
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citation: Nepal Ministry of Health, Department of Health Services Annual Report 2000- 2001, Kathmandu
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citation: Haugen J, Basnet S, Hardang IM, Sharma A, Mathisen M, Shrestha P, Valentiner-Branth P, Strand TA. Vitamin D status is associated with treatment failure and duration of illness in Nepalese children with severe pneumonia. Pediatr Res. 2017 Dec;82(6):986-993. doi: 10.1038/pr.2017.71. Epub 2017 Aug 16.
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