Congenital Heart Disease (CHD)RCTNCT06789640
Impact of Vitamin C Supplementation on Hospital Outcomes in Children Undergoing Corrective Heart Surgery for Congenital Heart Diseases
A study testing Vitamin C in people with Congenital Heart Disease (CHD), run by Cairo University.
Trial summary
Vitamin C will be given before admission in the immediate preoperative preceding 7 days (the dose 30 -45 mg per day ) in oral drops preparations Inflammatory markers including CRP , TLC ,PNI , GPS NLR will be checked on admission and on discharge and compared between cases and controls Hospital length stay will also… Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Congenital Heart Disease (CHD)
- What is being tested?
- Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 19 Feb 2025to 19 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children in the first two years who will be for corrective surgery for heart diseases congenital heart diseases
- Pediatric patients whose parents or caregivers agree to be enrolled in the study.
- Risk Adjustment for Congenital Heart Surgery -1 (RACHS-1) for Evaluation of Mortality in Children Undergoing Cardiac Surgery : the first two categories (Thiagarajan and C. Laussen 2015)
Who cannot join
- Pediatric patients with associated comorbid conditions.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Vitamin C Supplementation on the Hospital Outcomes in Children Undergoing Corrective Heart Surgery for Congenital Heart Diseases
Vitamin C will be given before admission in the immediate preoperative preceding 7 days (the dose 30 -45 mg per day ) in oral drops preparations
Inflammatory markers including CRP , TLC ,PNI , GPS NLR will be checked on admission and on discharge and compared between cases and controls Hospital length stay will also be compared between the two groups
- Conditions
- Congenital Heart Disease (CHD)
- Being tested
- Vitamin C, Placebo
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin COther
Vitamin C will be given before admission in the immediate preoperative preceding 7 days (the dose 30 -45 mg per day ) in oral drops preparations
Inflammatory markers including CRP , TLC ,PNI , GPS NLR will be checked on admission and on discharge and compared between cases and controls Hospital length stay will also be compared between the two groups
PlaceboOther
Placebo will be given before admission in the immediate preoperative preceding 7 days (the dose 30 -45 mg per day ) in oral drops preparations
Inflammatory markers including CRP , TLC ,PNI , GPS NLR will be checked on admission and on discharge and compared between cases and controls
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Vitamin C will be given before admission in the immediate preoperative preceding 7 days (the dose 30 -45 mg per day ) in oral drops preparations
Inflammatory markers including CRP , TLC ,PNI , GPS NLR will be checked on admission and on discharge and compared between cases and controls Hospital length stay will also be compared between the two groups Receives: Other: Vitamin C |
| The control group | Placebo comparator | A placebo will be given before admission in the immediate preoperative preceding 7 days (the dose 30 -45 mg per day ) in oral drops preparations
Inflammatory markers including CRP , TLC ,PNI , GPS NLR will be checked on admission and on discharge and compared between cases and controls Hospital length stay will also be compared between the two groups Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvemnents of Ejection Fraction between the two groups
Each group wil be evaluated for the eiection fraction before and after the operation and the improvement will be compared
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start19 Feb 2025 (estimated)
- Primary completion19 Apr 2025 (estimated)
- Study completion19 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoda Atef Abdelsattar Ibrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789640
- Sponsor's protocol ID
- MS-588-2023
- Other IDs
- MS-588-2023
- Acronym
- RCT
- Status last verified
- Feb 2025
- First submitted
- 17 Jan 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vitamin C Supplementation on the Hospital Outcomes in Children Undergoing Corrective Heart Surgery for Congenital Heart Diseases
- ClinicalTrials.gov ID
- NCT06789640
- Acronym / sponsor ID
- RCT / MS-588-2023
- Conditions
- Congenital Heart Disease (CHD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 19 Feb 2025 (estimated)
- Primary completion
- 19 Apr 2025 (estimated)
- Study completion
- 19 Apr 2025 (estimated)
- First posted
- 23 Jan 2025 (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.
Vitamin C will be given before admission in the immediate preoperative preceding 7 days (the dose 30 -45 mg per day ) in oral drops preparations
Inflammatory markers including CRP , TLC ,PNI , GPS NLR will be checked on admission and on discharge and compared between cases and controls Hospital length stay will also be compared between the two groups
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Other: Vitamin CVitamin C will be given before admission in the immediate preoperative preceding 7 days (the dose 30 -45 mg per day ) in oral drops preparations Inflammatory markers including CRP , TLC ,PNI , GPS NLR will be checked on admission and on discharge and compared between cases and controls Hospital length stay will also be compared between the two groups |
| The control group | Placebo comparator | Other: PlaceboA placebo will be given before admission in the immediate preoperative preceding 7 days (the dose 30 -45 mg per day ) in oral drops preparations Inflammatory markers including CRP , TLC ,PNI , GPS NLR will be checked on admission and on discharge and compared between cases and controls Hospital length stay will also be compared between the two groups |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children in the first two years who will be for corrective surgery for heart diseases congenital heart diseases
- Pediatric patients whose parents or caregivers agree to be enrolled in the study.
- Risk Adjustment for Congenital Heart Surgery -1 (RACHS-1) for Evaluation of Mortality in Children Undergoing Cardiac Surgery : the first two categories (Thiagarajan and C. Laussen 2015)
Key exclusion criteria (1 listed)
- Pediatric patients with associated comorbid conditions.
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 CVitamin C will be given before admission in the immediate preoperative preceding 7 days (the dose 30 -45 mg per day ) in oral drops preparations Inflammatory markers including CRP , TLC ,PNI , GPS NLR will be checked on admission and on discharge and compared between cases and controls Hospital length stay will also be compared between the two groups | Other | Interventional |
| PlaceboPlacebo will be given before admission in the immediate preoperative preceding 7 days (the dose 30 -45 mg per day ) in oral drops preparations Inflammatory markers including CRP , TLC ,PNI , GPS NLR will be checked on admission and on discharge and compared between cases and controls | Other | The control group |
Primary outcome
The improvemnents of Ejection Fraction between the two groups
Time frame: 7-10 days
Each group wil be evaluated for the eiection fraction before and after the operation and the improvement will be compared
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C in people with Congenital Heart Disease (CHD), run by Cairo University.
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 3 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: opening soon, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hoda Atef Abdelsattar Ibrahim (hodaibrahim424@gmail.com, hodaibrahim4242@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvemnents of Ejection Fraction between the two groups (time frame: 7-10 days). 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 17 Feb 2025.