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Clinical trial

Zinc Supplementation in Pediatric Sepsis; a Randomized Controlled Trial

ID
Name
MS.19.05.614
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.
Trial arms
Trial start
2019-07-31
Estimated PCD
2022-06-10
Trial end
2022-08-01
Status
Completed
Phase
Early phase I
Treatment
oral zinc sulfate
Oral zinc sulfate at dose 10 to 20 mg daily for 10 days
Arms:
Treatment group
Size
72
Primary endpoint
Mortality rate
through study completion an average of one year
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 72, 'type': 'ACTUAL'}}
Updated at
2023-03-03

1 organization

1 product

1 indication

Organization
Mansoura University
Product
Zinc Sulfate
Indication
Zinc in Pediatric Sepsis