NCT01062009

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

August 20, 2019

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

5.9 years

First QC Date

February 2, 2010

Results QC Date

August 16, 2016

Last Update Submit

August 19, 2019

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (2)

  • Plasma Zinc Concentration Over Time

    Plasma Zinc levels were measured daily during the seven day study period in each group.

    7 days

  • New Fever

    Because of reports of fever in patients wiht zinc overdoses, we monitored patients for new fever while on supplementation

    7 days

Secondary Outcomes (1)

  • Glucose Homeostasis

    7 days

Study Arms (4)

Control group

NO INTERVENTION

No intervention

Low dose group

ACTIVE COMPARATOR

250 mcg/kg/day supplemental IV zinc sulfate divided every 8 hours for 7 days

Drug: Zinc sulfate

Medium dose group

ACTIVE COMPARATOR

500 mcg/kg/day supplemental IV zinc sulfate q8 hours for 7 days

Drug: Zinc sulfate

High dose group

ACTIVE COMPARATOR

750 mcg/kg/day supplemental IV zinc sulfate q8 hrs for 7 days

Drug: Zinc sulfate

Interventions

Zinc sulfateDRUG

Zinc sulfate 200 mcg/ml in Normal Saline

High dose groupLow dose groupMedium dose group

Eligibility Criteria

Age30 Days - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Childrens' Hospital & Research Center Oakland

Oakland, California, 94611, United States

Location

Related Publications (2)

  • Cvijanovich NZ, King JC, Flori HR, Gildengorin G, Wong HR. Zinc homeostasis in pediatric critical illness. Pediatr Crit Care Med. 2009 Jan;10(1):29-34. doi: 10.1097/PCC.0b013e31819371ce.

    PMID: 19057435BACKGROUND

  • Wong HR, Shanley TP, Sakthivel B, Cvijanovich N, Lin R, Allen GL, Thomas NJ, Doctor A, Kalyanaraman M, Tofil NM, Penfil S, Monaco M, Tagavilla MA, Odoms K, Dunsmore K, Barnes M, Aronow BJ; Genomics of Pediatric SIRS/Septic Shock Investigators. Genome-level expression profiles in pediatric septic shock indicate a role for altered zinc homeostasis in poor outcome. Physiol Genomics. 2007 Jul 18;30(2):146-55. doi: 10.1152/physiolgenomics.00024.2007. Epub 2007 Mar 20.

    PMID: 17374846BACKGROUND

MeSH Terms

Conditions

Critical Illness

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsInorganic ChemicalsZinc Compounds

Limitations and Caveats

Small sample size in each group, with multiple comparisons. The study population was varied in age and diagnosis. Plasma zinc does not reflect total body zinc status, therefore a patient with low plasma Zn may not have true zinc deficiency.

Results Point of Contact

Title
Natalie Cvijanovich, MD
Organization
UCSF Benioff Childrens Hospital Oakland
NCvijanovich@mail.cho.org
510-428-3784

Study Officials

  • Natalie Z Cvijanovich, MD

    UCSF Benioff Children's Hospital Oakland

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2010

First Posted

February 4, 2010

Study Start

November 1, 2008

Primary Completion

October 1, 2014

Study Completion

November 1, 2014

Last Updated

August 20, 2019

Results First Posted

August 20, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)