Vitamin E and Infection in the Elderly
Primary Purpose
Respiratory Infection, Elderly
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin E
Sponsored by
About this trial
This is an interventional trial for Respiratory Infection focused on measuring Vitamin E
Eligibility 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:
Sites / Locations
- Tufts University
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00758914
First Posted
September 22, 2008
Last Updated
September 23, 2008
Sponsor
Tufts University
1. Study Identification
Unique Protocol Identification Number
NCT00758914
Brief Title
Vitamin E and Infection in the Elderly
Official Title
Vitamin E and Infection in the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
May 1997 (undefined)
Primary Completion Date
August 2001 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Tufts University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Infection, Elderly
Keywords
Vitamin E
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin E
Intervention Description
200 IU alpha-tocopherol or placebo for 1 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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:
Facility Information:
Facility Name
Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20484443
Citation
Belisle SE, Hamer DH, Leka LS, Dallal GE, Delgado-Lista J, Fine BC, Jacques PF, Ordovas JM, Meydani SN. IL-2 and IL-10 gene polymorphisms are associated with respiratory tract infection and may modulate the effect of vitamin E on lower respiratory tract infections in elderly nursing home residents. Am J Clin Nutr. 2010 Jul;92(1):106-14. doi: 10.3945/ajcn.2010.29207. Epub 2010 May 19.
Results Reference
derived
Learn more about this trial
Vitamin E and Infection in the Elderly
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