Locally made ready to use therapeutic food for treatment of malnutrition a randomized controlled trial.

OBJECTIVE To evaluate the effectiveness of a locally made ready-to-use therapeutic food (RUTF) in decreasing mild to moderate malnutrition. DESIGN A randomized open label, controlled trial. SETTING Pre-schools run by the Department of Community Health in Kaniyambadi administrative block, Vellore, India; duration of follow-up 3 months from the date of recruitment. PARTICIPANTS Pupils aged 18 -60 months with Weight-for-Age 2 SD. INTERVENTIONS A locally produced energy-dense supplement (RUTF), and the current standard of care [teaching caregivers how to make a fortified cereal-milk supplement called High Calorie Cereal Milk (HCCM)]. MAIN OUTCOME MEASURES Increase in weight-for-age status; increase in levels of plasma zinc, vitamin B12, serum albumin and haemoglobin. RESULTS The Mean (SD) weight gain at 3 months was higher in the RUTF group: RUTF (n=51): 0.54 kg; (SE = 0.05; 95% CI = 0.44 - 0.65) vs HCCM (n=45): 0.38 kg;(SE = 0.06; 95% CI = 0.25 - 0.51), P = 0.047. The weight gain per kilogram of body weight was directly proportional to the severity of malnutrition. CONCLUSIONS Community-based treatment showed weight gain in both groups, the gain being higher with RUTF.