A double-blind controlled clinical trial on the efficacy and safety of the use of L-alanine oral rehydration solution (ORS) in the management of acute diarrhea in children

ABSTRACT

The addition of a neutral amino acid like l-alanine to an ORS has been found to enhance sodium and water reabsorption. A double-blind randomized trial was conducted to determine the efficacy and safety of using an ORS containing 90 mmol/L of l-alanine and 90 mmol/L of glucose as compared to the standard WHO-ORS in the management of acute diarrhea in children. Included were 140 male patients, 3-36 months, with a history of 3 or more watery stools in the past 24 hours of not more than 5 days, with signs of moderate to severe dehydration and with weight for length /_ 70% of NCHS standards. Rehydration was done following WHO recommendations using either the standard or l-alanine ORS. Feedings, in the form of breastmilk, formula and/or semi-solids were resumed thereafter. Stools were replaced by volume with ORS until diarrhea ceased. The clinical and laboratory characteristics of the 2 groups, 70 each, were comparable before intervention. Mean diarrheal duration was similar in both groups after intervention (71 +/_ 50 vs 60 +/_ 31 hours in the l-alanine ORS and WHO-ORS groups respectively). No difference was observed between the two formulations for all other variables except the mean urine output on the 6th-24th hours (40 vs. 31 ml/kg body weight/day, p = 0.05) which was greater in the l-alanine group. Further studies among infants and children have to be conducted to determine the optimal osmolality of the solution and amino acid and glucose concentration.