The Effect of Adjunct Vitamin a on Community-Acquired Pneumonia in Southern Iranian Children: a Randomized Clinical Trial (CAP Vitamin A)

November 5, 2024 updated by: Mohammad Bagher Rahmati, Hormozgan University of Medical Sciences
This randomized clinical trial included 105 children with CAP who were admitted to Bandar Abbas Children's Hospital. Participants were randomly assigned to two groups: a control group receiving standard antibiotic therapy and an intervention group receiving standard antibiotics plus vitamin A (25,000 IU for 2 days). Key data collected included age, sex, duration of hospitalization, treatment duration, and daily Respiratory Index of Severity in Children (RISC) scores.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Children to present with CAP symptoms

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Hormozgan
      • Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 7915893664
        • Hormozgan University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • children to present with CAP symptoms, including fever, cough, pulmonary rales, respiratory distress (age-adjusted tachypnea: >50 breaths per minute for infants under 1 year, >40 for ages 1-5 years, and >30 for those over 5 years), and radiographic findings indicative of pneumonia.

Exclusion Criteria:

  • underlying immunodeficiency, chronic respiratory conditions, concurrent use of immunosuppressive medications, prior high-dose vitamin A intake, and hospitalizations shorter than 24 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: a control group
the control group received standard antibiotic therapy
Experimental: the intervention group received standard antibiotics plus adjunctive vitamin A supplementation
the intervention group received standard antibiotics plus adjunctive vitamin A supplementation (25,000 IU daily for two days)
Dietary supplement: Vitamin A
the intervention group received standard antibiotics plus adjunctive vitamin A supplementation (25,000 IU daily for two days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of hospitalization
Time Frame: Key data collected included age, sex, duration of hospitalization, treatment duration, and daily Respiratory Index of Severity in Children (RISC) scores.
Vitamin A supplementation was associated with a significant reduction in hospitalization duration in children with CAP, supporting its potential as an adjunct therapy.
Key data collected included age, sex, duration of hospitalization, treatment duration, and daily Respiratory Index of Severity in Children (RISC) scores.
Treatment duration daily Respiratory Index of Severity in Children (RISC) scores
Time Frame: From enrollment to the end of treatment and discharge of patients ( 6 months)
daily Respiratory Index of Severity in Children (RISC) scores
From enrollment to the end of treatment and discharge of patients ( 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hormozgan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 18, 2021

Study Registration Dates

First Submitted

November 1, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Estimated)

November 7, 2024

Study Record Updates

Last Update Posted (Estimated)

November 7, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.HUMS.REC.1400.113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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