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Vitamin E and Infection in the Elderly

This study has been completed.
Sponsor:
Information provided by:
Tufts University
ClinicalTrials.gov Identifier:
NCT00758914
First received: September 22, 2008
Last updated: September 23, 2008
Last verified: September 2008
History of Changes
  Purpose

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:

MedlinePlus related topics: Vitamin E
U.S. FDA Resources

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.
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758914

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

No publications provided by Tufts University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Simin Nikbin Meydani, DVM, PhD, Tufts University
ClinicalTrials.gov Identifier: NCT00758914     History of Changes
Other Study ID Numbers: 1R01AG013975
Study First Received: September 22, 2008
Last Updated: September 23, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts University:
Vitamin E

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 17, 2013