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Micronutrient

Zinc Therapy for Critical Illness

Phase 1
Waitlist Available
Led By Renee D Stapleton, MD, PhD
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up several time points over one week during critical illness
Awards & highlights

Study Summary

This trial is a study to test if zinc can help improve outcomes for people with sepsis, a life-threatening condition caused by infection. 40 people with sepsis and 15 healthy controls will receive either zinc or a placebo for 7 days. Blood will be drawn to test if zinc affects inflammation, immunity, and oxidative stress response.

Eligible Conditions
  • Sepsis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study days 1, 3, and 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and study days 1, 3, and 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetics/pharmacodynamics
Secondary outcome measures
Neutrophil phagocytosis
Plasma IL-1beta
Plasma IL-6
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Zinc in severe sepsisExperimental Treatment1 Intervention
Mechanically ventilated patients with severe sepsis will be randomized to receive IV zinc or placebo
Group II: Healthy Volunteers receiving zincExperimental Treatment1 Intervention
Cohort of healthy volunteers will receive a single dose of 500 mcg/kg IBW IV zinc and pharmacokinetics will be measured for 8 hours. PK in sepsis patients and healthy volunteers will be compared.
Group III: Severe sepsis without zincPlacebo Group1 Intervention
Mechanically ventilated patients with severe sepsis will be randomized to receive IV zinc or placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zinc sulfate
2021
Completed Phase 3
~540

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of VermontLead Sponsor
266 Previous Clinical Trials
3,743,636 Total Patients Enrolled
1 Trials studying Sepsis
58 Patients Enrolled for Sepsis
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,441 Total Patients Enrolled
10 Trials studying Sepsis
8,465 Patients Enrolled for Sepsis
Renee D Stapleton, MD, PhDPrincipal InvestigatorUniversity of Vermont
1 Previous Clinical Trials
142 Total Patients Enrolled

Media Library

Zinc Sulfate (Micronutrient) Clinical Trial Eligibility Overview. Trial Name: NCT01162109 — Phase 1
Sepsis Clinical Trial 2023: Zinc Sulfate Highlights & Side Effects. Trial Name: NCT01162109 — Phase 1
Zinc Sulfate (Micronutrient) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01162109 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
University of Vermont College of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Zinc Therapy in Critical Illness
Renee Stapleton 2010. "Zinc Therapy in Critical Illness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01162109.
~4 spots leftby Apr 2025
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