Vitamin E and Infection in the Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00758914
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : September 25, 2008
Information provided by:
Tufts University

Brief 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.

Condition or disease Intervention/treatment Phase
Respiratory Infection Elderly Dietary Supplement: Vitamin E Not Applicable

Study Type : Interventional  (Clinical Trial)
Official Title: Vitamin E and Infection in the Elderly
Study Start Date : May 1997
Actual Primary Completion Date : August 2001

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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00758914

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

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 )
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: September 25, 2008
Last Verified: September 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