Zinc Intervention in Elderly for Prevention of Pneumonia

NCT05527899 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: R34HL153277
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Zinc Deficiency

Outcome Measures

Primary Outcomes (1)

• Zn levels

  serum and intracellular Zn levels

  12 months

Secondary Outcomes (3)

• T cell profile

  12 months

• T cell proliferation

  12 months

• side effects

  12 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

½ RDA of micronutrients including 5 mg/d Zn

Drug: Zinc gluconate

Zinc 30 mg

EXPERIMENTAL

½ RDA of micronutrients including 30 mg/d Zn

Drug: Zinc gluconate

Zinc 60 mg

EXPERIMENTAL

½ RDA of micronutrients including 60 mg/d Zn

Drug: Zinc gluconate

Interventions

Zinc gluconate DRUG

30 and 60 mg/d of zinc gluconate

Placebo; Zinc 30 mg; Zinc 60 mg

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• BMI\>18 kg/m2 and albumin \>3.0 g/dL

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Tufts University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• Ortega 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.

  PMID: 38450236 DERIVED

MeSH Terms

Interventions

gluconic acid

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: We will conduct a double-blind, randomized, and controlled trial (RCT) in elderly NH residents with low serum Zn levels (\< 70 μg/dL ) to evaluate the efficacy of 1 y of 30 or 60 mg/d Zn supplementation on serum and T cell Zn levels, and T cell number and function. There will be a placebo group. Neither participants, nor Investgators or Outcome Assessors will be aware of treatment group. Masking will be done over RedCap Software and participants will be assigned to groups A, B, or C.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 6, 2022
• Study Start: May 3, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

US (1)