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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital & Research Center Oakland; UCSF Benioff Children's Hospital Oakland
• Collaborator: Children's Hospital Medical Center, Cincinnati
• Treatments: Zinc; Zinc Sulfate

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