The Effect of Adjuvant Zinc Therapy on Recovery from Pneumonia in Hospitalized Children: A Double-Blind Randomized Controlled Trial

Last registered on December 30, 2013
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Pre-Trial

Trial Information

General Information

Title
The Effect of Adjuvant Zinc Therapy on Recovery from Pneumonia in Hospitalized Children: A Double-Blind Randomized Controlled Trial
RCT ID
AEARCTR-0000187
First published
December 30, 2013, 11:18 AM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Country
Iran (Islamic Republic of)
Region
Qum
Country
Iran (Islamic Republic of)
Region
Qum

Primary Investigator

Name
Ehsan Jangholi
Affiliation
Contact Primary Investigator

Other Primary Investigator(s)

Additional Trial Information

Status
Completed
Start date
2012-06-01
End date
2013-06-30
Keywords
Health
Additional Keywords
Randomized Controlled Trial, Pneumonia, Adjuvant Therapy, Zinc, Children
JEL code(s)
Secondary IDs
Abstract
Objectives: The present study aimed to investigate the effects of adjuvant zinc therapy on recovery from pneumonia in hospitalized children.
Methods: In a double-blind randomized controlled trial at Ayatollah Golpaygani Hospital in Qom, 120 children aged 3-60 months with pneumonia randomly received zinc (5 ml BID) or placebo along with the common antibiotic treatments until discharge. It was assumed that this element (zinc) was effective in resolving clinical symptoms and duration of hospitalization.
Results: Compared to the placebo group, the group receiving zinc showed a statistically significant decrease in duration of clinical symptoms (p = 0.044) and hospitalization (p = 0.004). The difference between frequency distributions of all clinical symptoms at admittance and the variables affecting the disease were not statistically significant (p > 0.05).
Conclusions: Supplemental administration of zinc can expedite the healing process and results in faster resolution of clinical symptoms in children with pneumonia. In general, zinc administration, along with common antibiotic treatments is recommended in this group of children. It can also reduce the drug resistance caused by multiple antibiotic therapies.
External Link(s)

Registration Citation

Citation
Jangholi, Ehsan. 2013. "The Effect of Adjuvant Zinc Therapy on Recovery from Pneumonia in Hospitalized Children: A Double-Blind Randomized Controlled Trial." AEA RCT Registry. December 30. https://doi.org/10.1257/rct.187-1.0
Former Citation
Jangholi, Ehsan. 2013. "The Effect of Adjuvant Zinc Therapy on Recovery from Pneumonia in Hospitalized Children: A Double-Blind Randomized Controlled Trial." AEA RCT Registry. December 30. https://www.socialscienceregistry.org/trials/187/history/779
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
The participants were randomly divided into two groups. One group received 10 ml (5 ml every 12 hours) of zinc daily and the other group received placebo.
Intervention Start Date
2012-06-01
Intervention End Date
2013-06-30

Primary Outcomes

Primary Outcomes (end points)
Then disease symptoms, duration of hospitalization, and duration of the resolution of clinical symptoms were investigated.
Primary Outcomes (explanation)
Then disease symptoms, duration of hospitalization, and duration of the resolution of clinical symptoms were investigated.

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
The participants were hospitalized at Ayatollah Golpaygani Hospital in Qom from June 2012 to June 2013. Moreover, the children’s parents completed and signed the informed written consent forms for conducting the study and the relevant experiments before entering the study.
The participants were randomly divided into two groups. One group received 10 ml (5 ml every 12 hours) of zinc daily and the other group received placebo.
Experimental Design Details
Randomization Method
Public lottery
Randomization Unit
blocks
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
120
Sample size: planned number of observations
120
Sample size (or number of clusters) by treatment arms
60
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
ethic committee of medical science university of Qom
IRB Approval Date
2012-04-12
IRB Approval Number
1137646125
Analysis Plan

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials