Zinc Therapy for Critical Illness
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether zinc (as zinc sulfate) can improve outcomes for people with severe sepsis, a life-threatening condition often caused by infection that leads to organ failure. Researchers aim to determine the optimal zinc dose and its effects on inflammation and the immune response. They will compare zinc levels between critically ill sepsis patients on mechanical ventilation and healthy volunteers. This study may suit someone with severe sepsis who is on a ventilator. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications, but you cannot participate if you have taken zinc supplements in the past month or are receiving TPN (total parenteral nutrition) with added zinc.
Is there any evidence suggesting that zinc therapy is likely to be safe for humans?
Research has shown that zinc is important for the immune system and overall health. Studies have found that administering zinc intravenously at 500 micrograms per kilogram per day was well-tolerated by patients, with no significant negative side effects at this dose. This treatment also improved blood zinc levels to a healthy range.
For healthy volunteers, similar doses of zinc were also safe. However, general warnings about zinc include potential eye irritation and harm to aquatic life if not handled properly. These concerns do not apply to clinical settings but are important for safe handling.
Overall, evidence suggests that zinc can be safely administered to both patients with sepsis and healthy individuals at the studied doses.12345Why do researchers think this study treatment might be promising for sepsis?
Unlike the standard treatments for severe sepsis, which typically involve antibiotics, fluids, and vasopressors to support blood pressure, zinc sulfate offers a potentially new approach by leveraging zinc's role in immune function and inflammation reduction. Researchers are excited about zinc because it acts as an antioxidant and may help modulate the body's immune response, which is crucial in managing the systemic inflammation seen in sepsis. Additionally, zinc sulfate's intravenous administration allows for precise dosing and rapid onset, which could be beneficial in critically ill patients who need swift intervention.
What evidence suggests that zinc therapy might be an effective treatment for sepsis?
Research has shown that zinc plays a crucial role in supporting the immune system and managing stress in the body. Many people with sepsis, a serious infection, lack sufficient zinc, which can worsen their condition. Animal studies demonstrated that extra zinc improved survival rates in sepsis. However, human studies did not consistently show reduced death rates or shorter ICU stays with zinc supplementation. This trial will compare the effects of zinc supplementation in different groups, including those with severe sepsis and healthy volunteers. Despite mixed results, zinc's role in immune support makes it a promising area for further research in treating sepsis.36789
Who Is on the Research Team?
Renee D Stapleton, MD, PhD
Principal Investigator
University of Vermont
Are You a Good Fit for This Trial?
This trial is for adults over 18 who are on mechanical ventilation due to severe sepsis. They shouldn't have taken zinc supplements recently, be pregnant or breastfeeding, have certain chronic diseases like AIDS with low CD4 count, significant kidney issues, or a history of organ transplant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous zinc or placebo for a total of 7 days, with dose-finding and pharmacokinetic testing
Pharmacokinetic Testing
Pharmacokinetic testing is performed to compare zinc metabolism in sepsis patients and healthy controls
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Zinc Sulfate
Trial Overview
The study tests different doses of intravenous zinc sulfate in critically ill patients with severe sepsis to find the right dose and see how it affects inflammation and immunity compared to healthy individuals. Patients will receive either zinc or placebo for up to 7 days.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Mechanically ventilated patients with severe sepsis will be randomized to receive IV zinc or placebo
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.
Mechanically ventilated patients with severe sepsis will be randomized to receive IV zinc or placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Vermont
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Citations
A Safety and Dose-escalation Study of Intravenous Zinc ...
Based on pharmacokinetic modeling, the 500 μg/kg/day IV zinc supplementation dose nearly restored levels to within the normal range, without inducing prolonged ...
Pharmacokinetics and Biodistribution of Zinc-Enriched ...
Maximum plasma concentration values were 3.87 and 2.81 μg/mL for ZnY and ZnSO4, respectively. Both ZnY and ZnSO4 were slowly eliminated with a ...
Zinc absorption as a function of the dose of zinc sulfate in ...
Conclusions. Increases in aqueous zinc doses >20 mg result in relatively small and progressively diminishing increases in AZ postabsorptively in healthy adults.
Pharmacokinetic study of orally administered zinc in humans
The absorption and distribution of the essential trace element zinc in humans was investigated in 10 subjects by performing a pharmacokinetic study.
Multi-Discipline Review - accessdata.fda.gov
Zinc is an essential trace element (TE) necessary in the diet to maintain health. Zinc Sulfate Injection provides 30 mg/ 10 ml (3 mg/ ml) and 25 ...
Zinc Sulfate / Concentrated Zinc Sulfate Injection, USP
Signal Word (GHS-US). : Warning. Hazard Statements (GHS-US). : H319 - Causes serious eye irritation. H402 - Harmful to aquatic life.
Zinc Sulfate Injection USP
Signal Word (GHS-US/CA). : Warning. Hazard Statements (GHS-US/CA). : H319 - Causes serious eye irritation. H401 - Toxic to aquatic life.
ZINC SULPHATE SOLUTION SAFETY DATA SHEET
Zinc Sulphate Solution causes serious eye irritation and is very toxic to aquatic life. Wear eye protection, avoid release, and wash skin after ...
Zinc Sulfate General Fact Sheet
Breathing in zinc sulfate can irritate the respiratory tract, cause nausea, vomiting, stomach ache, dizziness, depression, metallic taste in the mouth, and ...
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