Back to resultsZinc Supplementation in Pediatric Sepsis
Primary Purpose
Zinc in Pediatric Sepsis
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
oral zinc sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Zinc in Pediatric Sepsis
Eligibility Criteria
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
Sites / Locations
- Mansoura University Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Treatment group
Control group
Arm Description
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
who didn't receive zinc sulfate supplementation.
Outcomes
Primary Outcome Measures
Mortality rate
Frequency of occurrence of death
Secondary Outcome Measures
Zinc level
serum zinc level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05366595
Brief Title
Zinc Supplementation in Pediatric Sepsis
Official Title
Zinc Supplementation in Pediatric Sepsis; a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
June 10, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zinc in Pediatric Sepsis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
who didn't receive zinc sulfate supplementation.
Intervention Type
Drug
Intervention Name(s)
oral zinc sulfate
Intervention Description
Oral zinc sulfate at dose 10 to 20 mg daily for 10 days
Primary Outcome Measure Information:
Title
Mortality rate
Description
Frequency of occurrence of death
Time Frame
through study completion an average of one year
Secondary Outcome Measure Information:
Title
Zinc level
Description
serum zinc level
Time Frame
after 10 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angi A Al Wakil, MD
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University Children's Hospital
City
Mansoura
ZIP/Postal Code
35511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared. Results will be published by the investigators in academic journals. Sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential interested collaborators
Learn more about this trial
Zinc Supplementation in Pediatric Sepsis
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