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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
  Purpose

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.


Condition Intervention Phase
Pediatrics
Critical Illness
 Drug: Zinc sulfate
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Safety and Dose-escalation Study of Zinc Supplementation in Pediatric Critical Illness

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital & Research Center Oakland:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: November 2008
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Active Comparator: Low dose group
Group receiving 250 mcg/kg/day supplemental IV zinc
 Drug: Zinc sulfate
Zinc sulfate 200 mcg/ml in Normal Saline
Active Comparator: Medium dose group
Group receiving 500 mcg/kg/day supplemental IV zinc
 Drug: Zinc sulfate
Zinc sulfate 200 mcg/ml in Normal Saline
Active Comparator: High dose group
Group receiving 750 mcg/kg/day supplemental IV zinc
 Drug: Zinc sulfate
Zinc sulfate 200 mcg/ml in Normal Saline

  Eligibility

Ages Eligible for Study:   up to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01062009

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

Locations
United States, California
Childrens' Hospital & Research Center Oakland Recruiting
Oakland, California, United States, 94611
Principal Investigator: Natalie Z Cvijanovich, MD            
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Natalie Z Cvijanovich, MD Children's Hospital & Research Center Oakland
  More Information

Publications:

Responsible Party: Natalie Z. Cvijanovich, MD, Childrens' Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT01062009     History of Changes
Other Study ID Numbers: SPID 0876
Study First Received: February 2, 2010
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Zinc
Zinc Sulfate
Trace Elements
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Astringents
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013