Zinc Supplementation in Pediatric Sepsis
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 31, 2019
CompletedFirst Submitted
Initial submission to the registry
May 4, 2022
CompletedFirst Posted
Study publicly available on registry
May 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedMarch 3, 2023
May 1, 2022
2.9 years
May 4, 2022
March 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality rate
Frequency of occurrence of death
through study completion an average of one year
Secondary Outcomes (1)
Zinc level
after 10 days of treatment
Study Arms (2)
Treatment group
ACTIVE COMPARATORwho 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
Control group
NO INTERVENTIONwho didn't receive zinc sulfate supplementation.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura University Children's Hospital
Al Mansurah, 35511, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angi A Al Wakil, MD
Mansoura University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
May 4, 2022
First Posted
May 9, 2022
Study Start
July 31, 2019
Primary Completion
June 10, 2022
Study Completion
August 1, 2022
Last Updated
March 3, 2023
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share
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