drugset / Trial / NCT01062009
Safety and Dose Escalation Study of Zinc Supplementation in Critically Ill Children
Phase 1/2
Completed
24 enrolled
UCSF Benioff Children's Hospital Oakland
Children's Hospital Medical Center, Cincinnati · collab
Non-randomizedParallel-groupOpen-labelOther
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.
Timeline
- Start
- 2008-11
- Primary completion
- 2014-10
- Completion
- 2014-11
Publications
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Zinc Sulfate | Unknown | 250 ug/kg | Intravenous |
| Comparator | Zinc Sulfate | Unknown | 500 ug/kg | Intravenous |
| Comparator | Zinc Sulfate | Unknown | 750 ug/kg | Intravenous |
Indications
No indication recorded.