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CompletedNCT06677684CAP Vitamin AUpdated Nov 7, 2024

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

An interventional study of Vitamin A in Community-Acquired Pneumonia and Vitamin a, sponsored by Hormozgan University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 6 Months to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-07.

Sponsored by Hormozgan University of Medical Sciences · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 9 months after the study started (first participant enrolled Feb 2021, registered Nov 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
6 Months to 12 Years
Sex
All
01

Study 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.

Read the detailed description

Children to present with CAP symptoms

02

Conditions studied

  • Community-Acquired Pneumonia
  • Vitamin a

Keywords

  • Community-acquired pneumonia
  • Vitamin A
  • Pediatrics
  • Hospitalization
  • Southern Iran
03

In context

Community-Acquired Pneumonia

324 studies on the registry are indexed under Community-Acquired Pneumonia; 77 are open to participants now.

This study's enrollment of 105 is below the median of 250 across 195 interventional studies indexed under Community-Acquired Pneumonia.

Browse Community-Acquired Pneumonia studies →

Lead sponsor

Hormozgan University of Medical Sciences is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • underlying immunodeficiency, chronic respiratory conditions, concurrent use of medications, prior high-dose vitamin A intake, and hospitalizations shorter than 24 hours
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
105 participants (actual)

Study arms

  • 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

Interventions

  • Dietary supplementVitamin A

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Key data collected included age, sex, duration of hospitalization, treatment duration, and daily Respiratory Index of Severity in Children (RISC) scores.

  2. Treatment duration daily Respiratory Index of Severity in Children (RISC) scores

    daily Respiratory Index of Severity in Children (RISC) scores

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

07

Study locations

1 site
  • Hormozgan University of Medical Sciences
    Bandar Abbas, Hormozgan 7915893664, Iran, Islamic Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2021 to primary completion in Sep 2021, 7 months.

Of 42 non-industry interventional studies with no phase under Community-Acquired Pneumonia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 38. This study's 7 months is below that.

Counting every sponsor, half of 43 studies reached it within 24 months; a quarter within 14 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2024
First posted
Nov 7, 2024
StartActual
Feb 1, 2021
Primary completionActual
Sep 1, 2021
CompletionActual
Sep 18, 2021
Last update
Nov 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06677684
Lead sponsor
Hormozgan University of Medical Sciences
Responsible party
Mohammad Bagher Rahmati (Facualty memeber Oh HUMS, Hormozgan University of Medical Sciences) — Principal investigator
First posted
Nov 7, 2024
Start date
Feb 1, 2021
Primary completion
Sep 1, 2021
Completion
Sep 18, 2021
Last update
Nov 7, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Vitamin A

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