Phase 2
Completed N=25
Safety and Dose Escalation Study of Zinc Supplementation in Critically Ill Children
Source: ClinicalTrials.gov NCT01062009 ↗Enrolled (actual)
25
Serious AEs
4.2%
Results posted
Aug 2019
Primary outcomePrimary: Plasma Zinc Concentration Over Time — 51.2; 36.4; 37.7; 43.4 mcg/dL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Zinc Concentration Over Time |
51.2; 36.4; 37.7; 43.4; 63.0; 42.1 | — |
| PRIMARY New Fever |
0; 2; 1; 0 | 0.24 |
| SECONDARY Glucose Homeostasis |
4; 3.5; 4; 2.5; 3.5; 3.5 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01062009). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.