- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07414693
Effect of Vitamin C on Length of Hospital Stay in Children With Severe Pneumonia
Efficacy of Vitamin C as an Adjunct to Standard Treatment in Severe Pneumonia in Children Under Five Years of Age: A Clinical Comparison
Severe pneumonia is a common and serious illness in young children and often requires hospital admission. This clinical trial aims to find out whether adding vitamin C to standard treatment can reduce the length of hospital stay in children under five years of age admitted with severe pneumonia.
The main question this study seeks to answer is:
Does giving vitamin C along with routine treatment help children with severe pneumonia recover faster and go home earlier compared to standard treatment alone?
In this study, 90 children aged 2 to 59 months who are admitted to the Children's Hospital Multan with severe pneumonia will take part. Severe pneumonia is defined by fast breathing, fever, cough, and one or more danger signs such as difficulty feeding, repeated vomiting, seizures, bluish discoloration of lips, or noisy breathing. Children with chronic lung disease or weakened immunity will not be included.
After parental consent, children will be randomly divided into two groups. One group will receive standard treatment only, which includes oxygen therapy and intravenous antibiotics according to hospital protocol. The second group will receive the same standard treatment plus a daily dose of vitamin C. Neither group will receive any experimental or unapproved therapy.
Researchers will closely monitor each child's recovery, including improvement in breathing rate, temperature, oxygen levels, and overall clinical condition. The child will be discharged when the treating physician determines that recovery criteria are met. The number of days spent in the hospital from the start of treatment until discharge will be recorded.
By comparing the average hospital stay between the two groups, this study aims to determine whether vitamin C is a useful and safe add-on treatment for severe pneumonia in young children. The findings may help improve care and reduce hospital stay for children with severe pneumonia in the future.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Muhammad S Principal Investigator, MBBS
- Phone Number: +92 302 2513701
- Email: msulaman1432@gmail.com
Study Contact Backup
- Name: Ayesha F Assistant Professor, FCPS
- Phone Number: +92 333 6163845
- Email: drayeshafayyaz@yahoo.com
Study Locations
-
-
Punjab Province
-
Multan Khurd, Punjab Province, Pakistan, 60000
- Recruiting
- Children Hospital and Institute of Child Health
-
Contact:
- Muhammad S Principal Investigator, MBBS
- Phone Number: +92 302 2513701
- Email: msulaman1432@gmail.com
-
Contact:
- Ayesha F Assistant Professor, FCPS
- Phone Number: +92 333 6163845
- Email: drayeshafayyaz@yahoo.com
-
Principal Investigator:
- Muhammad S Principal Investigator, MBBS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- presenting with severe pneumonia
- ≤ 48-hours duration
Exclusion Criteria:
- Congenital heart disease
- Children with chronic respiratory illnesses i.e. Asthma, post tuberculosis bronchiectasis and cystic fibrosis
- Immunosuppressed i.e. primary immune deficiency, malignancy, on steroid therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard care
Standard care alone
|
Antibiotics Plus supportive care including oxygen inhalation, intravenous rehydration, and antipyretics
|
|
Experimental: Adjunct Vitamin C
Standard care plus vitamin C
|
Antibiotics Plus supportive care including oxygen inhalation, intravenous rehydration, and antipyretics
Standard care (oxygen inhalation, intravenous rehydration, and antipyretics) plus Vitamin C: 200-mg (2 cc = 4 dropper, should be mixed in milk or water) once a day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital Stay
Time Frame: From randomization to hospital discharge, assessed at discharge (up to 30 days).
|
Duration of Hospital Stay in days
|
From randomization to hospital discharge, assessed at discharge (up to 30 days).
|
Collaborators and Investigators
Investigators
- Study Chair: Ayesha F Assitant Professor, FCPS, Children Hospital and Institute of Child Health, Multan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1334-9511
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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