Impact of Vitamin C Supplementation on Hospital Outcomes in Children Undergoing Corrective Heart Surgery for Congenital Heart Diseases

NCT ID: NCT06789640

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-19

Study Completion Date

2025-04-19

Brief Summary

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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

Detailed Description

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Conditions

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Congenital Heart Disease (CHD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Interventional

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

Group Type EXPERIMENTAL

Vitamin C

Intervention Type OTHER

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

The control group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Vitamin C

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

Intervention Type OTHER

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* Pediatric patients with associated comorbid conditions.
Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hoda Atef Abdelsattar Ibrahim

Hoda Atef Abdelsattar Ibrahim

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Hoda Atef Abdelsattar Ibrahim

Role: CONTACT

Other Identifiers

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MS-588-2023

Identifier Type: OTHER

Identifier Source: secondary_id

MS-588-2023

Identifier Type: -

Identifier Source: org_study_id

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