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

NCT06677684 | Completed DMC

• 1 other identifier: IR.HUMS.REC.1400.113
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Community-Acquired Pneumonia; Vitamin a

Keywords

Community-acquired pneumonia; Vitamin A; Pediatrics; Hospitalization; Southern Iran

Outcome Measures

Primary Outcomes (2)

• duration of hospitalization

  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

  daily Respiratory Index of Severity in Children (RISC) scores

  From enrollment to the end of treatment and discharge of patients ( 6 months)

Study Arms (2)

a control group

NO INTERVENTION

the control group received standard antibiotic therapy

the intervention group received standard antibiotics plus adjunctive vitamin A supplementation

EXPERIMENTAL

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

Dietary Supplement: Vitamin A

Interventions

Vitamin A DIETARY_SUPPLEMENT

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

the intervention group received standard antibiotics plus adjunctive vitamin A supplementation

Eligibility Criteria

• Age: 6 Months - 12 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hormozgan University of Medical Sciences: lead

Study Sites (1)

Hormozgan University of Medical Sciences

Bandar Abbas, Hormozgan, 7915893664, Iran

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Facualty memeber Oh HUMS

Model Details: 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).

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 7, 2024
• Study Start: February 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 18, 2021
• Last Updated: November 7, 2024

Record last verified: 2021-02

Locations

IR (1)