Zinc Intervention in Elderly for Prevention of Pneumonia

• Status: Recruiting
• Trial end date: 2024-10-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tufts University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Criteria

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 control supplement

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 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 requiring chemotherapy 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 to affect 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 will postpone enrollment to 4 wks after PNA symptoms have cleared.