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Pneumonia | Zinc as Adjunct to Treatment of Pneumonia

Pneumonia research study

What is the primary objective of this study?

The propose of this study is to evaluate if zinc given as an adjunct to standard treatment of severe pneumonia in young children shortens the duration and reduces treatment failure, and if these effects are pathogen-dependant.

Who is eligible to participate?

Inclusion Criteria: - Children from 2 to 59 months of age with severe pneumonia admitted to the Children´s Hospital, whose parents are willing to provide written informed consent will be eligible for participation Exclusion Criteria: - Children suffering from marasmus or kwashiorkor, measles, pneumonia due to aspiration of a foreign body, hepatic or renal disease, sepsis, congenital abnormalities (cardiac, renal, or genetic), complicated pneumonia (lung abscess, pleural effusion, pneumatocele, atelectasis), or severe anemia (hemoglobin less than 8 g/dL [this cut-off is based on clinical experience with severe anemia at high altitude]) - Children whose parents refuse to provide written informed consent.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pneumonia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Dietary Supplement:Zinc sulphateArm X : Zinc sulphate 10 mg will be given orally twice a day since admission to resolution of pneumonia episode in addition to standard antibiotic treatment.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

X: Zinc sulphate

Study Status

Unknown status

Start Date: August 2007

Completed Date: May 2010

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Time (hours) to resolution of clinical signs of pneumonia

Secondary Outcome: Time (hours) to resolution of clinical signs of pneumonia by type of associated pathiogens ( bacterial/viral)

Study sponsors, principal investigator, and references

Principal Investigator: Fernando E Sempertegui, MD

Lead Sponsor: Corporacion Ecuatoriana de Biotecnologia

Collaborator: Boston University

More information:https://clinicaltrials.gov/show/NCT00513929

Sempértegui F, Estrella B, Correa E, Aguirre L, Saa B, Torres M, Navarrete F, Alarcón C, Carrión J, Rodríguez, Griffiths JK. Effects of short-term zinc supplementation on cellular immunity, respiratory symptoms, and growth of malnourished Equadorian children. Eur J Clin Nutr. 1996 Jan;50(1):42-6.

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