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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT01062009
First received: February 2, 2010
Last updated: July 31, 2013
Last verified: July 2013
  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
Pediatric 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:


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: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
No intervention
Active Comparator: Low dose group
250 mcg/kg/day supplemental IV zinc sulfate divided every 8 hours for 7 days
Drug: Zinc sulfate
Zinc sulfate 200 mcg/ml in Normal Saline
Active Comparator: Medium dose group
500 mcg/kg/day supplemental IV zinc sulfate q8 hours for 7 days
Drug: Zinc sulfate
Zinc sulfate 200 mcg/ml in Normal Saline
Active Comparator: High dose group
750 mcg/kg/day supplemental IV zinc sulfate q8 hrs for 7 days
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
  • New diagnosis of brain injury, encephalopathy
  • Clinical contraindication for zinc supplementation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Childrens' Hospital & Research Center Oakland
Oakland, California, United States, 94611
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: Children's 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: July 31, 2013
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 September 16, 2014