Zinc Intervention in Elderly for Prevention of Pneumonia (NCT05527899) | Clinical Trial Compass
CompletedPhase 2/3
Zinc Intervention in Elderly for Prevention of Pneumonia
United States105 participantsStarted 2022-05-03
Plain-language summary
Pneumonia is a major public health problem for the elderly and is one of the leading causes of hospitalization and death for this population, particularly for elderly nursing home residents. This planning grants seeks to establish a safe and effective dose of zinc supplementation with the goal to conduct a larger randomized clinical trial to study the effect of zinc supplementation in nursing home elderly with low serum zinc levels on the risk, antibiotic use, and duration of sick days with pneumonia. This project has significant potential to positively impact the health and quality of life in the elderly and to reduce the economic costs associated with their care.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Elderly males and females (≥65 years)
. \>6 mo life expectancy, as judged by physician
. Willing to be randomized into study groups
. Able to swallow pills
. Not currently on antibiotics
. If consuming RDA levels of supplement, willing to replace with our control supplement
. Calcium, vitamin D, and iron supplements permitted
. Willing to receive influenza vaccine
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Anticipated transfer or discharge within 3 months of enrollment
. Bed- or room-bound continuously for previous 3 months
. Presence of lung neoplastic diseases or other active neoplastic diseases requiring chemotherapy and/or immunosuppressive drugs (including ≤10 mg/day prednisone)
. Naso-gastric or other tube feeding
. Long-term (≥30 days) IV or urethral catheters
. Presence of tracheostomy or chronically ventilator-dependent
. Chronic prophylactic antibiotic treatment or long term antibiotics
. Those with PEM defined as albumin \<3.0 g/dl and BMI \<18kg/m2, 10