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

NCT ID: NCT06677684

Last Updated: 2024-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-09-18

Brief Summary

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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.

Detailed Description

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Children to present with CAP symptoms

Conditions

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Community-Acquired Pneumonia Vitamin a

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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a control group

the control group received standard antibiotic therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

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)

Group Type EXPERIMENTAL

Vitamin A

Intervention Type DIETARY_SUPPLEMENT

the intervention group received standard antibiotics plus adjunctive vitamin A supplementation (25,000 IU daily for two days)

Interventions

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Vitamin A

the intervention group received standard antibiotics plus adjunctive vitamin A supplementation (25,000 IU daily for two days)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hormozgan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Bagher Rahmati

Facualty memeber Oh HUMS

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hormozgan University of Medical Sciences

Bandar Abbas, Hormozgan, Iran

Site Status

Countries

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Iran

Other Identifiers

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IR.HUMS.REC.1400.113

Identifier Type: -

Identifier Source: org_study_id

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