Zinc Supplementation in Pediatric Sepsis

Study Overview
=================
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.

Official Title
-----------------
Zinc Supplementation in Pediatric Sepsis; a Randomized Controlled Trial

Conditions
-----------------
Zinc in Pediatric Sepsis

Intervention / Treatment
-----------------
* Drug: oral zinc sulfate


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group<br>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<br>* Oral zinc sulfate at dose 10 to 20 mg daily for 10 days<br>|
| No Intervention: Control group<br>who didn't receive zinc sulfate supplementation. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate | Frequency of occurrence of death | through study completion an average of one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Zinc level | serum zinc level | after 10 days of treatment |