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

Completed · Phase 1/Phase 2

Conditions studied: Critical Illness

In brief

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.

Key facts

Study ID

NCT01062009

Run by

UCSF Benioff Children's Hospital Oakland

People needed

24

Starts

2008-11-01

Expected to finish

2014-11-01

Last updated by the study team

2019-08-20

Who can join

Age: 0 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Childrens' Hospital & Research Center Oakland — Oakland, California, United States

Full record on ClinicalTrials.gov

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