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Completed

NCT Number: NCT05366595

Zinc Supplementation in Pediatric Sepsis

a single blinded randomized controlled clinical trial that was conducted to evaluate the role of zinc supplementation in improving the outcome of infants and children with sepsis in pediatric intensive care unit.

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Key information

Age range

2 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mansoura University Children's Hospital

Al Mansurah, 35511, Egypt

About this study

a single blinded randomized controlled clinical trial that was conducted to evaluate the role of zinc supplementation in improving the outcome of infants and children with sepsis in pediatric intensive care unit.

The study included 72 cases that were randomly divided into 2 groups

A- Group A (Zinc treated group):

Included 36 cases who received oral zinc sulfate supplementation at doses ranging from 10 mg (infants) to 20 mg (under-five children) of elemental zinc per day, a dosage that is safe in these children.

B- Group B:

Included 36 cases who didn't receive zinc sulfate supplementation.

Method of randomization:

The cases were randomly divided into two groups using the closed envelope technique. The numbers from 1 to 72 were written in flat pieces of papers and put in closed envelopes that were randomly distributed to the participants.

The cases with the odds number were allocated to the zinc treated group while the cases with the even numbers were allocated to the other group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 2- Pediatric patients who fulfill Pediatric Consensus criteria for definition of severe sepsis as 1) greater than or equal to 2 age-based systemic inflammatory response syndrome criteria, 2) confirmed or suspected invasive infection, and 3) cardiovascular dysfunction, acute respiratory distress syndrome, or greater than or equal to 2 organ system dysfunctions

Exclusion criteria

  • Infants and children with history of prematurity (< 37 weeks), chronic cardiopulmonary disease, immunodeficiency, neuromuscular disease, surgical conditions and any other chronic medical condition.
  • Those who are regularly taking vitamin or mineral supplementations

Treatment and study plan

oral zinc sulfate

Drug

Oral zinc sulfate at dose 10 to 20 mg daily for 10 days

Primary outcomes

  1. Mortality rate

    Time frame: through study completion an average of one year

    Frequency of occurrence of death

Secondary outcomes

  1. Zinc level

    Time frame: after 10 days of treatment

    serum zinc level

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Zinc Supplementation in Pediatric Sepsis; a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 9, 2022
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.