Perioperative Zinc Supplementation and Pediatric Colonic Surgical Recovery

NCT07760493 | Enrolling By Invitation

• 1 other identifier: Pediatric Zinc Trial
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled clinical trial is to evaluate the role of perioperative zinc supplementation on postoperative outcomes (specifically gastrointestinal mucosal integrity and inflammation) in children aged 1 month to 18 years undergoing elective or semi-urgent colonic surgery with anastomosis. The main questions it aims to answer are:

• Does perioperative zinc supplementation significantly optimize complete blood count (CBC) parameters, serum C-reactive protein (CRP), and serum zinc levels at 48 hours and 5 days postoperatively?
• Does zinc supplementation improve secondary clinical outcomes, such as wound healing scores on day 7, time to full enteral feeds, and length of hospital stay? Researcher will compare Group A (routine postoperative care plus perioperative zinc supplementation) to Group B (routine postoperative care only) to see if the zinc supplement enhances gut integrity, downregulates systemic inflammation, and reduces postoperative clinical complications. Participants will:
• Undergo their scheduled elective or semi-urgent colonic surgery with anastomosis.
• Be randomly assigned to receive either routine postoperative care alone or routine care supplemented with perioperative zinc.
• Provide blood samples at baseline (preoperatively), 48 hours postoperatively, and 5 days postoperatively for sequential monitoring of CBC, CRP, and serum zinc levels.
• Undergo clinical and ward assessments during hospitalization until day 7 to monitor clinical parameters (e.g., fever, timing of passage of stool/gases) and wound healing scores.

Conditions

Colonic Surgery

Outcome Measures

Primary Outcomes (3)

• Zinc Level

  Baseline, 48 hrs post-surgery and 5 days post-surgery

• CRP quantitative

  Baseline, 48 hrs post-surgery and 5 days post-surgery

• CBC

  Complete blood count

  Baseline, 48 hrs post-surgery and 5 days post-surgery

Secondary Outcomes (6)

• Fever (°C)

  Within 7 days post surgery

• Wound healing score

  On day 7 post-surgery

• • Time to full enteral feeds (hours).

  through study completion, an average of 1 year

• Length of hospital stay (days)

  Perioperative

• Bowel movement return (Days)

  Within 7 days post surgery

Study Arms (2)

Treatment Group

EXPERIMENTAL

Group Receiving Perioperative Zinc Supplementation beside the standard care

Drug: Perioperative Zinc Supplementation

Control Group

NO INTERVENTION

Group receiving only standard care

Interventions

Perioperative Zinc Supplementation DRUG

Giving Perioperative Zinc (7 days +/-2 pre-surgery and 7 days +/- 2 post-surgery)

Also known as: Adjuvant Perioperative Zinc Therapy

Treatment Group

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age: 1 month to 18 years.
• Undergoing elective or semi urgent colonic surgery with anastomosis (e.g., Hirschsprung's disease, anorectal malformations, colonic atresia, colonic resection, closure of colostomy).
• Parent/guardian able to give informed consent and agree to follow-up.

You may not qualify if:

• Preoperative serum zinc deficiency
• Development of major postoperative surgical complications that would interfere with the intervention or outcome assessment.
• Known severe renal impairment (eGFR below local pediatric threshold).
• Known severe hepatic failure.
• Current participation in another interventional trial that would interfere with outcomes.
• Immunodeficiency (primary or secondary) or neutropenia (because of atypical healing responses).
• Neonates \<1 month old (due to safety and dosing differences).

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Nile of Hope Hospital

Alexandria, Alexandria Governorate, 21539, Egypt

Location

Study Officials

• Noha A. Hamdy, Associate Professor

  Faculty of Pharmacy, Alexandria University

  STUDY DIRECTOR

• Zeina A. Taha, Bachelor

  Faculty of Pharmacy, Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: August 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 12, 2026

Record last verified: 2026-06

Locations

EG (1)