Design of clinical studies for evaluation of nutritional therapy in renal failure

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Abstract
Factors distinguishing most nutritional studies from those in the general realm of biomedicine are enumerated and discussed. Among these are problems of whole body response, body reserves, multiple actions of simple nutrients, bioequivalence of different nutrients, and divergence of results of short-term and long-term studies. Nutrition studies in patients with renal disease are complicated further by a set of factors unique to the specific underlying kidney disorder and by the fact that the patient with chronic progressive renal failure displays a gamut of gradual, but significant, changes in his excretory capacity and in his metabolic and endocrine internal millieu. A critical review of the appropriate literature is presented. Desirable characteristics of nutritional studies in such patients are discussed with particular emphasis on design features that increase the accuracy and statistical validity of outcome data and the conclusions drawn from them. Particular needs for comparative studies are discussed. Recommendations are made for development of protocols for larger-scale, longitudinal comparisons of specific nutritional therapies for patients with chronic renal failure.