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Randomized Controlled Trial Multicenter Study Clinical Trial
Vitamin E and respiratory tract infections in elderly nursing home residents: a randomized controlled trial.
- Simin Nikbin Meydani, Lynette S Leka, Basil C Fine, Gerard E Dallal, Gerald T Keusch, Maria Fiatarone Singh, and Davidson H Hamer.
- Nutritional Immunology Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Mass 02111, USA. simin.meydani@tufts.edu
- JAMA. 2004 Aug 18; 292 (7): 828836828-36.
ContextRespiratory tract infections are prevalent in elderly individuals, resulting in increased morbidity, mortality, and use of health care services. Vitamin E supplementation has been shown to improve immune response in elderly persons. However, the clinical importance of these findings has not been determined.ObjectiveTo determine the effect of 1 year of vitamin E supplementation on respiratory tract infections in elderly nursing home residents.Design, Setting, And ParticipantsA randomized, double-blind, placebo-controlled trial was conducted from April 1998 to August 2001 at 33 long-term care facilities in the Boston, Mass, area. A total of 617 persons aged at least 65 years and who met the study's eligibility criteria were enrolled; 451 (73%) completed the study.InterventionVitamin E (200 IU) or placebo capsule administered daily; all participants received a capsule containing half the recommended daily allowance of essential vitamins and minerals.Main Outcome MeasuresIncidence of respiratory tract infections, number of persons and number of days with respiratory tract infections (upper and lower), and number of new antibiotic prescriptions for respiratory tract infections among all participants randomized and those who completed the study.ResultsVitamin E had no significant effect on incidence or number of days with infection for all, upper, or lower respiratory tract infections. However, fewer participants receiving vitamin E acquired 1 or more respiratory tract infections (60% vs 68%; risk ratio [RR], 0.88; 95% confidence interval [CI], 0.76-1.00; P =.048 for all participants; and 65% vs 74%; RR, 0.88; 95% CI, 0.75-0.99; P =.04 for completing participants), or upper respiratory tract infections (44% vs 52%; RR, 0.84; 95% CI, 0.69-1.00; P =.05 for all participants; and 50% vs 62%; RR, 0.81; 95% CI, 0.66-0.96; P =.01 for completing participants). When common colds were analyzed in a post hoc subgroup analysis, the vitamin E group had a lower incidence of common cold (0.67 vs 0.81 per person-year; RR, 0.83; 95% CI, 0.68-1.01; P =.06 for all participants; and 0.66 vs 0.83 per person-year; RR, 0.80; 95% CI, 0.64-0.98; P =.04 for completing participants) and fewer participants in the vitamin E group acquired 1 or more colds (40% vs 48%; RR, 0.83; 95% CI, 0.67-1.00; P =.05 for all participants; and 46% vs 57%; RR, 0.80; 95% CI, 0.64-0.96; P =.02 for completing participants). Vitamin E had no significant effect on antibiotic use.ConclusionsSupplementation with 200 IU per day of vitamin E did not have a statistically significant effect on lower respiratory tract infections in elderly nursing home residents. However, we observed a protective effect of vitamin E supplementation on upper respiratory tract infections, particularly the common cold, that merits further investigation.
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