NCT00513929

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

Enrollment Period

2.8 years

First QC Date

August 7, 2007

Last Update Submit

January 27, 2009

Conditions

Pneumonia

Keywords

Severe PneumoniaZincAssociated pathogensSevere Pneumonia by type of associated pathogensSevere Pneumonia by basal plasma zinc status

Outcome Measures

Primary Outcomes (1)

  • Time (hours) to resolution of clinical signs of pneumonia

    31 months

Secondary Outcomes (1)

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

    31 months

Study Arms (1)

X: Zinc sulphate

EXPERIMENTAL
Dietary Supplement: Zinc sulphate

Interventions

Zinc sulphateDIETARY_SUPPLEMENT

Arm 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.

X: Zinc sulphate

Eligibility Criteria

Age2 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baca Ortiz Children´s Hospitals

Quito, Ecuador

RECRUITING

Related Publications (3)

  • Sempertegui F, Estrella B, Correa E, Aguirre L, Saa B, Torres M, Navarrete F, Alarcon C, Carrion J, Rodriguez, 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.

    PMID: 8617190BACKGROUND

  • Jonnalagadda S, Rodriguez O, Estrella B, Sabin LL, Sempertegui F, Hamer DH. Etiology of severe pneumonia in Ecuadorian children. PLoS One. 2017 Feb 9;12(2):e0171687. doi: 10.1371/journal.pone.0171687. eCollection 2017.

    PMID: 28182741DERIVED

  • Sempertegui F, Estrella B, Rodriguez O, Gomez D, Cabezas M, Salgado G, Sabin LL, Hamer DH. Zinc as an adjunct to the treatment of severe pneumonia in Ecuadorian children: a randomized controlled trial. Am J Clin Nutr. 2014 Mar;99(3):497-505. doi: 10.3945/ajcn.113.067892. Epub 2014 Jan 15.

    PMID: 24429536DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsInorganic ChemicalsZinc Compounds

Study Officials

  • Fernando E Sempertegui, MD

    Corporacion Ecuatoriana de Biotecnologia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando E Sempertegui, MD

CONTACT

593 2 2520638fersempert@andinanet.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 7, 2007

First Posted

August 9, 2007

Study Start

August 1, 2007

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

January 29, 2009

Record last verified: 2009-01

Locations

EC(1)