Safety and Dose Escalation Study of Zinc Supplementation in Critically Ill Children

This study is currently recruiting participants.

Verified June 2011 by Children's Hospital & Research Center Oakland

Sponsor:

Collaborator:

Children's Hospital Medical Center, Cincinnati

Information provided by:

Children's Hospital & Research Center Oakland

ClinicalTrials.gov Identifier:

NCT01062009

First received: February 2, 2010

Last updated: June 21, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 2, 2010

Last Updated Date

June 21, 2011

Start Date ^ICMJE

November 2008

Estimated Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Plasma zinc concentration [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01062009 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Glucose homeostasis [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Lymphocyte counts [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Healthcare associated infection [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Development/resolution of multiple organ failure [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Dose Escalation Study of Zinc Supplementation in Critically Ill Children

Official Title ^ICMJE

A Safety and Dose-escalation Study of Zinc Supplementation in Pediatric Critical Illness

Brief Summary

The purpose of the study is 1) to determine whether administration of intravenous zinc to critically ill children is safe, and 2) to determine an appropriate dose of zinc supplementation.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label

Condition ^ICMJE

Pediatrics
Critical Illness

Intervention ^ICMJE

Drug: Zinc sulfate

Zinc sulfate 200 mcg/ml in Normal Saline

Study Arm (s)

No Intervention: Control group
Active Comparator: Low dose group
Group receiving 250 mcg/kg/day supplemental IV zinc

Intervention: Drug: Zinc sulfate
Active Comparator: Medium dose group
Group receiving 500 mcg/kg/day supplemental IV zinc

Intervention: Drug: Zinc sulfate
Active Comparator: High dose group
Group receiving 750 mcg/kg/day supplemental IV zinc

Intervention: Drug: Zinc sulfate

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Admission to pediatric intensive care unit
Age between 1 month and 10 years
Pediatric Risk of Mortality III score > 5, OR presence of at least 1 new organ failure
Anticipated pediatric intensive care unit length of stay > 3 days
Ability of parent or legal guardian to provide informed consent

Exclusion Criteria:

Known zinc deficiency
Pre-existing bone marrow failure
New or existing diagnosis of diabetes mellitus
Limitation of care orders in place
Clinical contraindication for zinc supplementation

Gender

Both

Ages

up to 10 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Natalie Z Cvijanovich, MD	510-428-3784	NCvijanovich@mail.cho.org
Contact: Hector R Wong, MD	513-636-4259	hector.wong@cchmc.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01062009

Other Study ID Numbers ^ICMJE

SPID 0876

Has Data Monitoring Committee

Yes

Responsible Party

Natalie Z. Cvijanovich, MD, Childrens' Hospital & Research Center Oakland

Study Sponsor ^ICMJE

Children's Hospital & Research Center Oakland

Collaborators ^ICMJE

Children's Hospital Medical Center, Cincinnati

Investigators ^ICMJE

Principal Investigator:

Natalie Z Cvijanovich, MD

Children's Hospital & Research Center Oakland

Information Provided By

Children's Hospital & Research Center Oakland

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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