Zinc Intervention in Elderly for Prevention of Pneumonia

Last updated: July 29, 2024
Sponsor: Tufts University
Overall Status: Completed

Phase

2/3

Condition

Pneumonia

Treatment

Zinc gluconate

Clinical Study ID

NCT05527899
R34HL153277
R34HL153277
  • Ages > 65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Elderly males and females (≥65 years)

  2. >6 mo life expectancy, as judged by physician

  3. Willing to be randomized into study groups

  4. Able to swallow pills

  5. Not currently on antibiotics

  6. If consuming RDA levels of supplement, willing to replace with our controlsupplement

  7. Calcium, vitamin D, and iron supplements permitted

  8. Willing to receive influenza vaccine

  9. BMI>18 kg/m2 and albumin >3.0 g/dL

Exclusion

Exclusion Criteria:

  1. Anticipated transfer or discharge within 3 months of enrollment

  2. Bed- or room-bound continuously for previous 3 months

  3. Presence of lung neoplastic diseases or other active neoplastic diseases requiringchemotherapy and/or immunosuppressive drugs (including ≤10 mg/day prednisone)

  4. Naso-gastric or other tube feeding

  5. Long-term (≥30 days) IV or urethral catheters

  6. Presence of tracheostomy or chronically ventilator-dependent

  7. Chronic prophylactic antibiotic treatment or long term antibiotics

  8. Those with PEM defined as albumin <3.0 g/dl and BMI <18kg/m2, 10

  9. Consumption of supplements containing more than the RDA level of nutrients known toaffect the immune response, i.e. vitamins E, C, B6, selenium, Zn, or beta-carotene

  10. Diagnosis of PNA or other infection at baseline will not exclude a subject, but willpostpone enrollment to 4 wks after PNA symptoms have cleared.

Study Design

Total Participants: 105
Treatment Group(s): 1
Primary Treatment: Zinc gluconate
Phase: 2/3
Study Start date:
May 03, 2022
Estimated Completion Date:
June 30, 2024

Study 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.

Connect with a study center

  • Jean Mayer USDA Human Nutrition Research Center on Aging

    Boston, Massachusetts 02111
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.