Zinc DeficiencyPhase 2/3ZIPPNCT05527899
Zinc Intervention in Elderly for Prevention of Pneumonia
A Phase 2/3 study testing Zinc gluconate in people with Zinc Deficiency, run by Tufts University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Zinc Deficiency
- What is being tested?
- Zinc gluconate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2022to 30 Jun 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
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- Calcium, vitamin D, and iron supplements permitted
- Willing to receive influenza vaccine
- BMI>18 kg/m2 and albumin >3.0 g/dL
Who cannot join
- 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
Show all 10Show fewer
- Chronic prophylactic antibiotic treatment or long term antibiotics
- Those with PEM defined as albumin <3.0 g/dl and BMI <18kg/m2, 10
- Consumption of supplements containing more than the RDA level of nutrients known to affect the immune response, i.e. vitamins E, C, B6, selenium, Zn, or beta-carotene
- Diagnosis of PNA or other infection at baseline will not exclude a subject, but will postpone enrollment to 4 wks after PNA symptoms have cleared.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging
Boston, Massachusetts, 02111
About this study
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.
Read the detailed description
Pneumonia (PNA) is a leading cause of death and a major public health problem in the elderly, particularly for nursing home (NH) residents. Thus, there is an urgent need for effective strategies to prevent PNA in elderly. An important predisposing factor that may account for the higher incidence of PNA in older adults is the age-associated decline in T cell function. Importantly, there are remarkable similarities between Zn deficiency and age-induced changes in T cells. The investigators have shown that 29% of NH residents have low serum Zn levels, which was associated with higher incidence and duration of PNA, and antibiotic use. Although our preliminary data strongly suggest that low serum Zn is an independent risk factor for PNA in the elderly, a controlled clinical trial is critically needed to determine the efficacy of Zn supplementation in PNA prevention in this population. The objective of the larger clinical trial that will pursue the studies proposed in this R34 is to determine the effects of Zn supplementation on PNA outcomes in NH elderly and to understand their mechanistic basis. The central hypothesis is that improving Zn status in NH elderly with low serum Zn will reduce the incidence and duration of PNA, and the frequency of antibiotic use, and that the effect of Zn is mediated mainly through the improvement of T cell function. The rationale for conducting the proposed clinical trial is to determine the value of Zn supplementation as an inexpensive, easily implemented intervention that would aid in the prevention of PNA in the elderly. In a previous study NH elderly with low serum Zn levels, who were supplemented with 30 mg/d of Zn and ½ RDA of essential micronutrients showed, on average, significantly improved serum Zn levels. However, only 58% of participant became serum Zn adequate. The investigators therefore hypothesize that either a higher dose or a longer duration of supplementation is required to achieve adequate serum Zn levels in all Zn deficient elderly. The rationale for conducting the proposed pilot study is to determine the most effective yet safe dose for Zn supplementation in NH residents to be used in the larger clinical trial described above. The Specific Aim of the proposed two-year, pilot study is to establish the optimal dose of supplemental Zn to achieve adequate Zn status, and improved T cell function in Zn deficient elderly. This will be accomplished by conducting a randomized, placebo-controlled, double-blind clinical trial to test the efficacy of supplementation with 30 or 60 mg/d of Zn for 12 months on serum and T cell Zn levels, T cell function, and adverse events. The findings of this proposal are scientifically essential, yet sufficient, to allow us to make definitive decisions that inform the final design of our planned clinical trial, which aims to establish the value of Zn supplementation as an inexpensive, easily implemented intervention that would aid in the prevention of PNA, limit the duration of PNA, and consequently reduce the need for antimicrobial therapy in the elderly.
- Conditions
- Zinc Deficiency
- Being tested
- Zinc gluconate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc gluconateDrug
30 and 60 mg/d of zinc gluconate
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | ½ RDA of micronutrients including 5 mg/d Zn Receives: Drug: Zinc gluconate |
| Zinc 30 mg | Experimental | ½ RDA of micronutrients including 30 mg/d Zn Receives: Drug: Zinc gluconate |
| Zinc 60 mg | Experimental | ½ RDA of micronutrients including 60 mg/d Zn Receives: Drug: Zinc gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zn levels
serum and intracellular Zn levels
Measured: 12 months
Secondary outcomes (3)
T cell profile
Total T cells, helper T cells, and cytotoxic T cells in PBMC will be determined by measuring populations of CD3, CD4, and CD8 positive cells, respectively, using flow cytometry.
Measured: 12 months
T cell proliferation
PBMC will be incubated in the presence of T cell mitogens Con A or PHA, or antibodies against CD3 (T cell receptor) and CD28 (T cell co-receptor) for 72 h. Cultures will be pulsed with 0.5 μCi [3H]-thymidine (Perkin Elmer) during the last 4 h of incubation and then harvested onto glass-fiber mats (Wallac) with a Perkin Elmer cell harvester (Perkin Elmer). Cell proliferation will be assessed by the amount of [3H]-thymidine incorporated into the DNA as determined with the liquid-scintillation counting with a Micro Beta 2 MicroPlate counter (Perkin Elmer).
Measured: 12 months
side effects
number of side effects will be recorded
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start3 May 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Zinc DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will conduct a randomized, double-blind, placebo-controlled trial (RCT) in elderly NH residents with low serum Zn levels to evaluate the efficacy of 1 y of Zn supplementation (dose to be determined during R34 planning grant) in the prevention of PNA. Eligible subjects will be randomly assigned to one of two groups: both groups will receive a capsule containing ½ Recommended Dietary Allowance (RDA) of all the essential micronutrients, including 5 mg of elemental Zn; the Zn-supplemented group's capsule will contain an additional mg Zn gluconate (total equiv. of dose to be determined during R34 grant). Suppl. duration will be 12 mo to account for seasonal variations in the incidence of PNA.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527899
- Sponsor's protocol ID
- R34HL153277
- Other IDs
- R34HL153277
- Acronym
- ZIPP
- Status last verified
- Jul 2024
- First submitted
- 29 Aug 2022
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ortega EF, Yao JH, Guo W, Boehm SK, Ergil E, Wu D, Meydani SN, Panda A. Correcting zinc deficiency in nursing home residents: a randomized trial comparing 30 and 60 mg/day elemental zinc supplementation. Front Nutr. 2026 Sep 30;13:1935770. doi: 10.3389/fnut.2026.1935770. eCollection 2026.
PubMed 42876725Ortega EF, Wu D, Guo W, Meydani SN, Panda A. Study protocol for a zinc intervention in the elderly for prevention of pneumonia, a randomized, placebo-controlled, double-blind clinical pilot trial. Front Nutr. 2024 Feb 21;11:1356594. doi: 10.3389/fnut.2024.1356594. eCollection 2024.
PubMed 38450236
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc Intervention in Elderly for Prevention of Pneumonia
- ClinicalTrials.gov ID
- NCT05527899
- Acronym / sponsor ID
- ZIPP / R34HL153277
- Conditions
- Zinc Deficiency
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 3 May 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pneumonia (PNA) is a leading cause of death and a major public health problem in the elderly, particularly for nursing home (NH) residents. Thus, there is an urgent need for effective strategies to prevent PNA in elderly. An important predisposing factor that may account for the higher incidence of PNA in older adults is the age-associated decline in T cell function. Importantly, there are remarkable similarities between Zn deficiency and age-induced changes in T cells. The investigators have shown that 29% of NH residents have low serum Zn levels, which was associated with higher incidence and duration of PNA, and antibiotic use. Although our preliminary data strongly suggest that low serum Zn is an independent risk factor for PNA in the elderly, a controlled clinical trial is critically needed to determine the efficacy of Zn supplementation in PNA prevention in this population. The objective of the larger clinical trial that will pursue the studies proposed in this R34 is to determine the effects of Zn supplementation on PNA outcomes in NH elderly and to understand their mechanistic basis. The central hypothesis is that improving Zn status in NH elderly with low serum Zn will reduce the incidence and duration of PNA, and the frequency of antibiotic use, and that the effect of Zn is mediated mainly through the improvement of T cell function. The rationale for conducting the proposed clinical trial is to determine the value of Zn supplementation as an inexpensive, easily implemented intervention that would aid in the prevention of PNA in the elderly. In a previous study NH elderly with low serum Zn levels, who were supplemented with 30 mg/d of Zn and ½ RDA of essential micronutrients showed, on average, significantly improved serum Zn levels. However, only 58% of participant became serum Zn adequate. The investigators therefore hypothesize that either a higher dose or a longer duration of supplementation is required to achieve adequate serum Zn levels in all Zn deficient elderly. The rationale for conducting the proposed pilot study is to determine the most effective yet safe dose for Zn supplementation in NH residents to be used in the larger clinical trial described above. The Specific Aim of the proposed two-year, pilot study is to establish the optimal dose of supplemental Zn to achieve adequate Zn status, and improved T cell function in Zn deficient elderly. This will be accomplished by conducting a randomized, placebo-controlled, double-blind clinical trial to test the efficacy of supplementation with 30 or 60 mg/d of Zn for 12 months on serum and T cell Zn levels, T cell function, and adverse events. The findings of this proposal are scientifically essential, yet sufficient, to allow us to make definitive decisions that inform the final design of our planned clinical trial, which aims to establish the value of Zn supplementation as an inexpensive, easily implemented intervention that would aid in the prevention of PNA, limit the duration of PNA, and consequently reduce the need for antimicrobial therapy in the elderly.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- We will conduct a randomized, double-blind, placebo-controlled trial (RCT) in elderly NH residents with low serum Zn levels to evaluate the efficacy of 1 y of Zn supplementation (dose to be determined during R34 planning grant) in the prevention of PNA. Eligible subjects will be randomly assigned to one of two groups: both groups will receive a capsule containing ½ Recommended Dietary Allowance (RDA) of all the essential micronutrients, including 5 mg of elemental Zn; the Zn-supplemented group's capsule will contain an additional mg Zn gluconate (total equiv. of dose to be determined during R34 grant). Suppl. duration will be 12 mo to account for seasonal variations in the incidence of PNA.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Zinc gluconate½ RDA of micronutrients including 5 mg/d Zn |
| Zinc 30 mg | Experimental | Drug: Zinc gluconate½ RDA of micronutrients including 30 mg/d Zn |
| Zinc 60 mg | Experimental | Drug: Zinc gluconate½ RDA of micronutrients including 60 mg/d Zn |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc gluconate30 and 60 mg/d of zinc gluconate | Drug | Placebo, Zinc 30 mg, Zinc 60 mg |
Primary outcome
Zn levels
Time frame: 12 months
serum and intracellular Zn levels
3 secondary outcomes
T cell profile
Time frame: 12 months
T cell proliferation
Time frame: 12 months
side effects
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 42876725Ortega EF, Yao JH, Guo W, Boehm SK, Ergil E, Wu D, Meydani SN, Panda A. Correcting zinc deficiency in nursing home residents: a randomized trial comparing 30 and 60 mg/day elemental zinc supplementation. Front Nutr. 2026 Sep 30;13:1935770. doi: 10.3389/fnut.2026.1935770. eCollection 2026.
- Derived from this study: PubMed 38450236Ortega EF, Wu D, Guo W, Meydani SN, Panda A. Study protocol for a zinc intervention in the elderly for prevention of pneumonia, a randomized, placebo-controlled, double-blind clinical pilot trial. Front Nutr. 2024 Feb 21;11:1356594. doi: 10.3389/fnut.2024.1356594. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Zinc gluconate in people with Zinc Deficiency, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zn levels (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05527899, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.