Zinc Supplementation in Pediatric Sepsis

Sponsor

Mansoura University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05366595

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Zinc in Pediatric Sepsis	Drug: oral zinc sulfate	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Zinc Supplementation in Pediatric Sepsis; a Randomized Controlled Trial

Actual Study Start Date :

Jul 31, 2019

Anticipated Primary Completion Date :

May 10, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment group who received oral zinc sulfate supplementation on dose 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	Drug: oral zinc sulfate Oral zinc sulfate at dose 10 to 20 mg daily for 10 days
No Intervention: Control group who didn't receive zinc sulfate supplementation.

Arm

Intervention/Treatment

Active Comparator: Treatment group

who received oral zinc sulfate supplementation on dose 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

Drug: oral zinc sulfate

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

No Intervention: Control group

who didn't receive zinc sulfate supplementation.

Outcome Measures

Primary Outcome Measures

Mortality rate [through study completion an average of one year]
Frequency of occurrence of death

Secondary Outcome Measures

Zinc level [after 10 days of treatment]
serum zinc level

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University Children's Hospital	Mansoura		Egypt	35511

Sponsors and Collaborators

Mansoura University

Investigators

Principal Investigator: Angi A Al Wakil, MD, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amal Osman, Assistant professor, Mansoura University

ClinicalTrials.gov Identifier:

NCT05366595

Other Study ID Numbers:

MS.19.05.614

First Posted:

May 9, 2022

Last Update Posted:

May 9, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Sepsis

Toxemia

Zinc Sulfate

Study Results

No Results Posted as of May 9, 2022