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Mineral Supplement
Zinc Supplementation for Pneumonia (ZIPP Trial)
Phase 2 & 3
Recruiting
Research Sponsored by Tufts University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Elderly males and females (≥65 years)
Not currently on antibiotics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
ZIPP Trial Summary
This trial seeks to study the effect of zinc supplementation on the risk, antibiotic use, and duration of sick days with pneumonia in nursing home elderly.
Who is the study for?
This trial is for elderly individuals aged 65 or older with a life expectancy of more than 6 months, who can swallow pills and are not on antibiotics. They must be willing to take zinc supplements instead of their current ones if needed, have a BMI over 18 kg/m2, an albumin level above 3.0 g/dL, and agree to get the flu vaccine.Check my eligibility
What is being tested?
The study is testing whether taking zinc gluconate supplements can reduce the risk of pneumonia in elderly people with low serum zinc levels. It aims to find a safe and effective dose that could decrease hospitalizations due to pneumonia.See study design
What are the potential side effects?
While specific side effects are not listed here, common side effects from taking zinc include nausea, vomiting, diarrhea, metallic taste in mouth, kidney and stomach damage if taken in high doses.
ZIPP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 65 years old or older.
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I am not taking antibiotics.
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I am taking calcium, vitamin D, and iron supplements.
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I am willing to get the flu shot.
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My BMI is over 18 and my albumin level is above 3.0 g/dL.
ZIPP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Zn levels
Secondary outcome measures
T cell profile
T cell proliferation
side effects
Side effects data
From 2019 Phase 4 trial • 23 Patients • NCT050963129%
vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Zinc Gluconate Group
Placebo Group
ZIPP Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Zinc 60 mgExperimental Treatment1 Intervention
½ RDA of micronutrients including 60 mg/d Zn
Group II: Zinc 30 mgExperimental Treatment1 Intervention
½ RDA of micronutrients including 30 mg/d Zn
Group III: PlaceboPlacebo Group1 Intervention
½ RDA of micronutrients including 5 mg/d Zn
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zinc gluconate
2018
Completed Phase 4
~450
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,819 Previous Clinical Trials
47,295,652 Total Patients Enrolled
Tufts UniversityLead Sponsor
260 Previous Clinical Trials
661,017 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 65 years old or older.I am on long-term antibiotics.I am not taking antibiotics.Your doctor believes you will live for more than 6 months.I have had an IV or urethral catheter for 30 days or more.I can join the study 4 weeks after my infection symptoms are gone.I have a tracheostomy or rely on a ventilator.I don't take high doses of immune-affecting supplements.I am taking calcium, vitamin D, and iron supplements.I am receiving nutrition through a feeding tube.I am willing to get the flu shot.My BMI is over 18 and my albumin level is above 3.0 g/dL.You have low levels of a protein called albumin in your body and a low body mass index (BMI).I have been confined to my bed or room for the last 3 months.I have cancer in my lungs or another active cancer needing strong medication.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Zinc 60 mg
- Group 3: Zinc 30 mg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are receiving care through this clinical trial?
"That is correct. Currently, the information available on clinicaltrials.gov shows that this study is looking for potential candidates. This trial was originally posted on 05/03/2022 and was edited on 09/12/2022. The study is looking for 105 patients from 1 site."
Answered by AI
Are we currently enrolling individuals in this research project?
"The medical trial is still looking for volunteers, as indicated by the information available on clinicaltrials.gov. This specific study was originally advertised on May 3rd, 2022 and underwent its most recent edit on September 12th, 2022."
Answered by AI
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