Clinical trial NCT00758914: Vitamin E and Infection in the Elderly
Official title: Vitamin E and Infection in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Infection
Elderly
Keywords: Vitamin E
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2008-09-25
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes

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.


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:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
Study officials:
References:
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.