Zinc Supplementation in Pediatric Sepsis

NCT ID: NCT05366595

Last Updated: 2023-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-31

Study Completion Date

2022-08-01

Brief Summary

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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

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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.

Conditions

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Zinc in Pediatric Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment group

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

Group Type ACTIVE_COMPARATOR

oral zinc sulfate

Intervention Type DRUG

Oral zinc sulfate at dose 10 to 20 mg daily for 10 days

Control group

who didn't receive zinc sulfate supplementation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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oral zinc sulfate

Oral zinc sulfate at dose 10 to 20 mg daily for 10 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Amal Osman

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angi A Al Wakil, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Mansoura University Children's Hospital

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MS.19.05.614

Identifier Type: -

Identifier Source: org_study_id

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