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

NCT06789640 | Not Yet Recruiting

• 1 other identifier: MS-588-2023
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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 be compared between the two groups

Conditions

Congenital Heart Disease (CHD)

Outcome Measures

Primary Outcomes (1)

• 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

  7-10 days

Study Arms (2)

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

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

Other: Placebo

Interventions

Vitamin C 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

Interventional

Placebo 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

The control group

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Pediatric patients with associated comorbid conditions.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Central Study Contacts

Hoda Atef Abdelsattar Ibrahim

CONTACT

hodaibrahim424@gmail.com; hodaibrahim4242@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hoda Atef Abdelsattar Ibrahim

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: February 19, 2025
• Primary Completion: April 19, 2025
• Study Completion: April 19, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02