Locally made ready-to-use therapeutic food for treatment of malnutrition: a Randomized Controlled Trial

Abstract

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.