Vitamin E and Infection in the Elderly

Elderly Clinical Trial

Official title:

Vitamin E and Infection in the Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758914
• Other study ID #: 1R01AG013975
• Status: Completed
• Phase: N/A
• First received: September 22, 2008
• Last updated: September 23, 2008
• Start date: May 1997

Study information

• Verified date: September 2008
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Aging is associated with a variety of changes in the immune system. These changes result in a less effective immune response, which places the elderly at a greater risk for infection and disease. Respiratory infections cause a great number of morbidity and mortality in the elderly population. Vitamin E has been known to improve the immune response of the elderly and has been suggested for use in preventative strategies for this population. The purpose of this study is to examine the effect of one year vitamin supplementation on respiratory infection in the elderly population residing in nursing homes. This study was conducted using a randomized, double blind, placebo controlled clinical trial at 33 long-term care facilities in the greater Boston area. A total of 617 subjects over the age of 65 were enrolled in the study, with 451 completers. The participants were supplemented wit either 200 IU of vitamin E per day or placebo. The primary outcomes consisted of respiratory tract infection, number of sick days, and antibiotic use. The study involved use of questionnaires, standard anthropometrics measurements, non-invasive body composition, blood and urine sample collection, and delayed type test (DTH) using the Mantoux method. This study has been closed since August 2000 and is in the stage of data analysis only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: August 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• aged 65 years or older;

• life expectancy greater than 6 months;

• no anticipated discharge within 3 months;

• not room-bound for the past 3 months;

• absence of active neoplastic disease;

• no tube feeding, no kidney dialysis;

• no intravenous or urethral catheters for the last 30 days;

• no tracheostomy or chronic ventilator;

• antibiotic-free for more than 2 weeks;

• no long-term steroid treatment greater than 10 mg/d, no use of immunosuppressive drugs, or greater than the recommended daily allowance (RDA) level of supplements of vitamins E, C, or B6, selenium, zinc, beta-carotene, or fish oil;

• body mass index of at least 18;

• serum albumin at least 3.0 g/dL; able to swallow pills;

• willing to receive influenza vaccine;

• willing to provide informed consent (for patients with dementia, family members provided informed consent)

Exclusion Criteria:

Study Design

N/A

Related Conditions & MeSH terms

• Elderly
• Infection
• Respiratory Infection
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Vitamin E
200 IU alpha-tocopherol or placebo for 1 year.

Locations

Country	Name	City	State
United States	Tufts University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States,