A randomized, double-blind, placebo-controlled trial of nutritional supplementation during acute illness.
OBJECTIVE
The study tested whether nutritional support of older patients during acute illness leads to a clinical benefit.


METHODS
In this randomized, double-blind, placebo-controlled study, we randomly assigned 445 hospitalized patients aged 65 to 92 years to receive either a normal hospital diet plus 400 mL oral nutritional supplements (223 subjects) or a normal hospital diet plus a placebo (222 subjects) daily for 6 weeks. The composition of the supplement was such as to provide 995 kcal of energy and 100% of the Reference Nutrient Intakes for vitamins and minerals for a healthy older person. Patients had three assessments: at baseline, at 6 weeks, and at 6 months post-randomization. Outcome measures were 6 months of disability, non-elective readmission and length of hospital stay, discharge destination, morbidity, and mortality.


RESULTS
Randomization to the supplement group led to a significant improvement in nutritional status. Over 6 months, 65 patients (29%) in the supplements group were readmitted to the hospital compared with 89 patients (40%) in the placebo group (adjusted hazard ratio 0.68 [95% confidence interval 0.49-0.94]). The mean length of hospital stay was 9.4 days in the supplements group compared with 10.1 days in the placebo group. Thirty-two people (14%) died in the supplement group compared with 19 people (9%) in the placebo group at 6 months (adjusted hazard ratio 1.65 [95% confidence interval, 0.93-2.92]).


CONCLUSIONS
Oral nutritional supplementation of acutely ill patients improved nutritional status and led to a statistically significant reduction in the number of non-elective readmissions.
Gariballa
Salah
S
Sheffield Institute for Studies on Ageing, University of Sheffield, United Kingdom. s.gariballa@uaeu.ac.ae
Forster
Sarah
S
Walters
Stephen
S
Powers
Hilary
H
D000208:Acute Disease / Q000401:mortality / Q000628:therapy*; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging; D004032:Diet; D019587:Dietary Supplements; D004311:Double-Blind Method; D004912:Erythrocytes; D005260:Female; D005492:Folic Acid / Q000097:blood; D006801:Humans; D008297:Male; D009747:Nutritional Physiological Phenomena; D009752:Nutritional Status; D010919:Placebos; D014805:Vitamin B 12 / Q000097:blood
D010919:Placebos; D005492:Folic Acid; D014805:Vitamin B 12