Zinc Supplementation in Pediatric Sepsis

Mansoura University

Status and phase: Completed; Phase 2

Conditions: Zinc in Pediatric Sepsis

Treatments: Drug: oral zinc sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT05366595

MS.19.05.614

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 2 months to 5 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

72 participants in 2 patient groups

Treatment group

Active Comparator group

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

Treatment:

Drug: oral zinc sulfate

Control group

No Intervention group

Description:

who didn't receive zinc sulfate supplementation.