Vitamin E and Infection in the Elderly

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.

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Key information

Conditions

Respiratory Infection Elderly Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts University

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin E

Dietary Supplement

200 IU alpha-tocopherol or placebo for 1 year.

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Important dates

Study start: 1997
Primary completion: 2001
First posted: Sep 25, 2008
Registry last updated: Sep 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed