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Vitamin E and Infection in the Elderly

This study has been completed.
Information provided by:
Tufts University Identifier:
First received: September 22, 2008
Last updated: September 23, 2008
Last verified: September 2008
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.

Condition Intervention
Respiratory Infection Elderly Dietary Supplement: Vitamin E

Study Type: Interventional
Official Title: Vitamin E and Infection in the Elderly

Resource links provided by NLM:

Further study details as provided by Tufts University:

Study Start Date: May 1997
Primary Completion Date: August 2001 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Vitamin E
    200 IU alpha-tocopherol or placebo for 1 year.

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:

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Please refer to this study by its identifier: NCT00758914

United States, Massachusetts
Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Simin Nikbin Meydani, DVM, PhD, Tufts University Identifier: NCT00758914     History of Changes
Other Study ID Numbers: 1R01AG013975 ( U.S. NIH Grant/Contract )
Study First Received: September 22, 2008
Last Updated: September 23, 2008

Keywords provided by Tufts University:
Vitamin E

Additional relevant MeSH terms:
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vitamin E
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents processed this record on August 18, 2017