SAFETY AND EFFECTIVENESS OF HOMEMADE AND RECONSTITUTED PACKET CEREAL-BASED ORAL REHYDRATION SOLUTIONS - A RANDOMIZED CLINICAL-TRIAL

Objectives. Parents may be deterred from obtaining commercial oral reh ydration solutions (ORS) for their young children with acute diarrheal disease because of its availability and/or cost, especially if they a re poor. We conducted a randomized clinical trial to determine 1) whet her low-income parents could safely mix and administer cereal-based OR S (CBORS) both from ingredients commonly found in the home and from a premixed packet; 2) whether these CBORS were as effective in maintaini ng hydration as commercial glucose-based ORS; and 3) whether CBORS wer e more effective in reducing severity and duration of illness. Methods . Children 4 to 36 months of age discharged from emergency departments and health centers with acute diarrheal disease were randomized to re ceive either homemade CBORS, reconstituted packet CBORS, or Pedialyte. A study nurse saw the child at home each day until the illness resolv ed, and obtained capillary blood for serum sodium at enrollment and at 24 to 48 hours; a sample of CBORS for sodium concentration; stool for pathogen analysis; and daily fluid intake, stool frequency, and weigh t. Results. A total of 232 children were enrolled, of whom 203 (88%) c ompleted the study. Two parents (3%) in the homemade CBORS group and o ne parent (1%) in the packet CBORS group made mixing errors resulting in a high sodium concentration (>100 mEq/L); their children refused th e solution and had normal serum sodium values. Mean CBORS sodium conce ntration for the remainder of the homemade CBORS group was 60 +/- 10 m Eq/L, and for the packet CBORS group, 54 +/- 13. Eighteen children (11 %) had abnormal serum sodium values at presentation, which returned to normal in all groups in most cases. Three children (4.5%) in the home made CBORS group, 4 (6%) in the packet CBORS group,and 1 child (1.4%) in the Pedialyte group failed therapy. Children refused to take homema de CBORS and packet CBORS (43% and 32%, respectively) more often than Pedialyte (9%), and those in the CBORS groups tended to take less ORS and total fluids. There were no significant differences among the thre e groups in incidence of daily vomiting or stooling, duration of diarr hea, or weight gain. Conclusions. CBORS do not offer a clinically sign ificant advantage over glucose-based ORS. Homemade CBORS represent a t reatment option in carefully selected cases, but it is not the safest alternative for regular clinical use.