ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01062009
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : January 28, 2015
Sponsor:
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Children's Hospital & Research Center Oakland

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.

Condition or disease Intervention/treatment Phase
Pediatric Critical Illness Drug: Zinc sulfate Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Safety and Dose-escalation Study of Zinc Supplementation in Pediatric Critical Illness
Study Start Date : November 2008
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Plasma zinc concentration [ Time Frame: 7 days ]
  2. Adverse events [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Glucose homeostasis [ Time Frame: 7 days ]
  2. Lymphocyte counts [ Time Frame: 3 days ]
  3. Healthcare associated infection [ Time Frame: 28 days ]
  4. Development/resolution of multiple organ failure [ Time Frame: 7 days ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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