The following contribution was prepared at the request of the Committee on Nutrition as a step towards filling a long-felt need, namely, statement of the essential principles governing scientific appraisal of nutritional substances through clinical trials with humans. It is necessary to ascertain the validity of methods which may be employed for this purpose before attempting to devise practicable plans for clinical testing of products. Only on this basis can the results of clinical trials be properly evaluated. Pediatricians and manufacturers of nutritional products have both been handicapped in selection of truly beneficial products because of lack of suitable criteria for judging the effect of substances on nutrition in the period of rapid growth and development in infancy and childhood.
The critique which follows is not to be construed as a recommendation that any one of the methods mentioned is a superior approach in the conduct of clinical trials of substances, nor does it constitute a simple plan for specific clinical trials. Instead, it is emphasized that "uncritical use" of any technique is valueless. If one of these methods is to be employed (especially indirect measurements, such as short-term balance studies), to secure information on the effects of a substance on growth and nutrition, the considerations outlined must be respected.
Definition of ideal or optimal nutrition is not attempted in this communication. That would present even greater difficulties of an almost philosophic nature. The methods discussed are concerned with comparison of the state of nutrition achieved in test- and control-groups by substances under appraisal, through the use of various available indices.
- Copyright © 1957 by the American Academy of Pediatrics