A Randomized, Double-Blind, Placebo-Controlled Trial of Nutritional Supplementation During Acute Illness

doi:10.1016/j.amjmed.2005.12.006

The American Journal of Medicine

Volume 119, Issue 8, August 2006, Pages 693-699

https://doi.org/10.1016/j.amjmed.2005.12.006 Get rights and content

Abstract

Purpose

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]).

Conclusion

Oral nutritional supplementation of acutely ill patients improved nutritional status and led to a statistically significant reduction in the number of non-elective readmissions.

Section snippets

Study Population

We randomized hospitalized patients aged 65 years or more to a normal hospital diet plus placebo (n = 222) versus a normal hospital diet plus oral supplements daily for 6 weeks (n = 223). Inclusion criteria were age 65 years or more, able to swallow, and able to sign an informed written consent form. Patients excluded from the study were those who had undergone gastric surgery, with diagnosed malabsorption or morbid obesity (body mass index > 40), in a coma, with diagnosed severe dementia

Randomization

The randomization sequence was generated by the trial statistician; concealed in sequentially numbered, sealed opaque envelopes; and kept in a clerical office at a different city. Contact was made by telephone for a trial medication number, and patient baseline details were recorded in the database.

Sample Size Calculation

In patients who have had a stroke, we previously showed that a 1 g/L lower serum albumin concentration in the hospital is associated with a 1.13-fold increase in the risk of death (95% confidence

Results

Between March 2001 and January 2004, 445 patients aged 65 to 92 years were recruited. Figure 1 details the recruitment and intervention process and 6-month follow-up.

Discussion

The results of this study indicate that nutritional supplementation of older people during acute illness and the convalescence/rehabilitation period significantly reduces non-elective 6-month readmission rates. These clinical benefits were observed despite the modest degree of adherence to taking the supplements. The improvements in readmission rate indices were accompanied by significant improvements in biomarkers of nutritional status in the supplement group, which were evident at 6 weeks and

Conclusion

This trial demonstrated that nutritional supplementation of hospitalized elderly people leads to a clinically important benefit. Widespread implementation of this strategy, taking into account patients’ preference, lifestyle, and socioeconomic circumstances, could have a substantial economic impact and improve the quality of life for older people.

Acknowledgments

Salah Gariballa was the lead investigator and prepared the first draft of the article. Sarah Forster undertook subjects’ recruitment and assessments. Stephen Walters was responsible for statistical analysis. Hilary Powers was a co-investigator. All investigators were involved in the study design and writing of the article.

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Clinical research studyA Randomized, Double-Blind, Placebo-Controlled Trial of Nutritional Supplementation During Acute Illness

Abstract

Purpose

Methods

Results

Conclusion

Section snippets

Study Population

Randomization

Sample Size Calculation

Results

Discussion

Conclusion

Acknowledgments

Nutrition

Am J Clin Nutr

Am J Clin Nutr

Am J Clin Nutr

Am J Clin Nutr

Am J Clin Nutr

Clin Nutr

Nutrition and older peoplespecial consideration for nutrition and ageing

Clin Med

Clinical research study
A Randomized, Double-Blind, Placebo-Controlled Trial of Nutritional Supplementation During Acute Illness