Working…
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
Results First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
UCSF Benioff Children's Hospital 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
Critical Illness Drug: Zinc sulfate Phase 1 Phase 2

Detailed Description:
Our recently published studies in children with septic shock demonstrated that pediatric septic shock is characterized by large scale repression of genes that either directly depend on normal zinc homeostasis or directly participate in zinc homeostasis. Functional validation studies demonstrated that nonsurvivors of pediatric septic shock have abnormally low serum zinc concentrations. A follow-up pilot study in a general population of critically ill children demonstrated that the presence of low plasma zinc concentrations is a prevalent problem in critically ill children. In addition, low plasma zinc concentrations correlate inversely with indices of inflammation and directly with the number of organ failures. These preliminary data, coupled with the expected safety of zinc supplementation, provided the rationale for a double blinded, prospective, placebo-controlled trial of zinc supplementation in critically ill children, with the two primary study endpoints to assess efficacy being highly clinically relevant: reduction of the lymphopenia rate and improvement of glucose homeostasis. Although the proposal was well-received, the primary concern precluding funding of this trial were lack of safety and dosing data for intravenous zinc. We have therefore developed a proposal for a Phase I/II study of safety and pharmacokinetics to address these concerns. It is anticipated that data generated through this proposal will provide the necessary preliminary data to re-submit our application for an interventional efficacy trial of zinc supplementation in critically ill children

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 Over Time [ Time Frame: 7 days ]
    Plasma Zinc levels were measured daily during the seven day study period in each group.

  2. New Fever [ Time Frame: 7 days ]
    Because of reports of fever in patients wiht zinc overdoses, we monitored patients for new fever while on supplementation


Secondary Outcome Measures :
  1. Glucose Homeostasis [ Time Frame: 7 days ]
    Patients were assigned a score based on glucose range to take into account the degree of hyperglycemia as well as the need for insulin over the course of the 7 day study period. This score is an ordinal scale ranging from 1 to 5, with a score of 1 indicating no hyperglycemia, and 5 indicating severe hyperglycemia despite insulin administration.



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.


Layout table for eligibility information
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
Layout table for location information
United States, California
Childrens' Hospital & Research Center Oakland
Oakland, California, United States, 94611
Sponsors and Collaborators
UCSF Benioff Children's Hospital Oakland
Children's Hospital Medical Center, Cincinnati
Investigators
Layout table for investigator information
Principal Investigator: Natalie Z Cvijanovich, MD UCSF Benioff Children's Hospital Oakland
Publications:
Layout table for additonal information
Responsible Party: UCSF Benioff Children's Hospital Oakland
ClinicalTrials.gov Identifier: NCT01062009    
Other Study ID Numbers: SPID 0876
First Posted: February 4, 2010    Key Record Dates
Results First Posted: August 20, 2019
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Critical Illness
Disease Attributes
Pathologic Processes
Zinc Sulfate
Astringents
Physiological Effects of Drugs
Dermatologic Agents