Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-26 @ 9:14 AM
Study NCT ID:
NCT05366595
Status:
COMPLETED
Last Update Posted:
2023-03-03
First Post:
2022-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zinc Supplementation in Pediatric Sepsis
Sponsor:
Mansoura University
Organization:
Study Overview
Official Title:
Zinc Supplementation in Pediatric Sepsis; a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: