Efficacy of F-100, diluted F-100, and infant formula as rehabilitation diet for infants aged <6 months with severe acute malnutrition: A randomized clinical trial

Full text: Introduction: The therapeutic milk F-100 is the standard diet for the inpatient rehabilitation phase of severe acute malnutrition in older children but the optimum dietary management of very young infants is not known. The specific concern of using F-100 for infants aged <6 months is its potential renal solute load and the possible risk of hypernatremic dehydration. Methods: A double blind randomized clinical trial comparing F-100, diluted F-100, and infant formula was conducted at the Nutrition Rehabilitation Unit, icddr,b, Dhaka, Bangladesh. One hundred and fifty-three infants aged <6 months with severe acute malnutrition were enrolled. After stabilization from acute illnesses, infants were randomly assigned to any of the three diets. During first 2 d, diets were fed at 130 ml/kg/d in 12 feeds and then 10 ml more at each feed until some is left. Diets were offered in 8 feeds thereafter. Two ml blood was collected on study days 1, 3, and 7 for measuring serum electrolytes, creatinine and osmolality. Urine samples were also tested for specific gravity and osmolality:creatinine. Renal solute load and potential renal solute were calculated. Infants were discharged when they gained 15% of the admission body weight or had oedema-free weight-for-length Z-score ≥ -2. Results: Infants fed F-100 had significantly higher energy intakes than the other two groups (480 ± 168, 410 ± 140 and 366 ± 111 kcal/day in F-100, diluted F-100 and infant formula respectively; p <0.0001) and recovered more quickly than infants fed infant formula but not more quickly than infants fed diluted F-100 (p=0.043). Gained significantly more weight when fed F-100 and F-100 diluted than those who received infant formula (p=0.023). Potential renal solute load was significantly more in those fed with F-100 (<0.0001), but was within normal limit. Urinary specific gravity was highest in the F-100 group but the values were all within the normal range. Serum electrolytes were constant and showed no sign of elevation in any group. Conclusions: F-100 can be safely used in the rehabilitation phase for infants <6 months with severe acute malnutrition and there is no need to prepare alternative formulations. (author)