Community-Acquired PneumoniaCAP Vitamin ANCT06677684
The Effect of Adjunct Vitamin a on Community-Acquired Pneumonia in Southern Iranian Children: a Randomized Clinical Trial
A study testing Vitamin A in people with Community-Acquired Pneumonia and Vitamin a, run by Hormozgan University of Medical Sciences at 1 site in Iran.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Community-Acquired Pneumonia, Vitamin a
- What is being tested?
- Vitamin A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteIran
- Study dates
- 1 Feb 2021to 18 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- underlying immunodeficiency, chronic respiratory conditions, concurrent use of immunosuppressive medications, prior high-dose vitamin A intake, and hospitalizations shorter than 24 hours
Trial locations and contacts
1 site in 1 country.
Iran1 site
Hormozgan University of Medical Sciences
Bandar Abbas, Hormozgan, 7915893664
About this study
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
- Conditions
- Community-Acquired Pneumonia, Vitamin a
- Being tested
- Vitamin A
- Keywords
- Community-acquired pneumonia, Vitamin A, Pediatrics, Hospitalization, Southern Iran
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin ADietary supplement
the intervention group received standard antibiotics plus adjunctive vitamin A supplementation (25,000 IU daily for two days)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Dietary Supplement: Vitamin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From enrollment to the end of treatment and discharge of patients ( 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Feb 2021
- Primary completion1 Sep 2021
- Study completion18 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-Acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hormozgan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Bagher Rahmati, Hormozgan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677684
- Sponsor's protocol ID
- IR.HUMS.REC.1400.113
- Acronym
- CAP Vitamin A
- Status last verified
- Feb 2021
- First submitted
- 1 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adjunct Vitamin a on Community-Acquired Pneumonia in Southern Iranian Children: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06677684
- Acronym / sponsor ID
- CAP Vitamin A / IR.HUMS.REC.1400.113
- Conditions
- Community-Acquired Pneumonia, Vitamin a
- Keywords
- Community-acquired pneumonia, Vitamin A, Pediatrics, Hospitalization, Southern Iran
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Hormozgan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 18 Sep 2021 (actual)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Children to present with CAP symptoms
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| a control group | No intervention | –the control group received standard antibiotic therapy |
| the intervention group received standard antibiotics plus adjunctive vitamin A supplementation | Experimental | Dietary Supplement: Vitamin Athe intervention group received standard antibiotics plus adjunctive vitamin A supplementation (25,000 IU daily for two days) |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- underlying immunodeficiency, chronic respiratory conditions, concurrent use of immunosuppressive medications, prior high-dose vitamin A intake, and hospitalizations shorter than 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin Athe intervention group received standard antibiotics plus adjunctive vitamin A supplementation (25,000 IU daily for two days) | Dietary supplement | the intervention group received standard antibiotics plus adjunctive vitamin A supplementation |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin A in people with Community-Acquired Pneumonia and Vitamin a, run by Hormozgan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.