RESUMEN
OBJECTIVE: To compare efficacy of indigenous Ready-to-use Therapeutic Food (Medical Nutrition Therapy) with Standard Nutrition Therapy in children with Severe acute malnutrition. DESIGN: Two facility-based and two community-based models: (i) Open prospective randomized controlled trial comparing Indigenous Ready-to-use Therapeutic Food (Medical Nutrition Therapy) with Standard Nutrition Therapy; (ii) Only Indigenous Ready-to-use Therapeutic Food (Medical Nutrition Therapy); (iii) Doorstep Child Care Centre; and (iv) Community-based Management of Acute Malnutrition. SETTING: (i) Urban Health Center, Dharavi, Mumbai; (ii) Two day care centers of Non-governmental Organization SNEHA - Mumbai; (iii) Urban slums, M East and L Ward, Mumbai. PARTICIPANTS: 1105 children aged 6-60 months in community or hospital inpatient/ outpatient department diagnosed as Severe Acute Malnutrition by WHO definition. INTERVENTION: All subjects received either Indigenous Ready-to-use Therapeutic Food (Medical Nutrition Therapy) or Standard Nutrition Therapy (protein calorie rich diet) for eight weeks and followed up for next four months. MAIN OUTCOME MEASURES: Mean rate of weight gain (g/kg/day), target weight, change in nutritional status. RESULTS: Rate of weight gain was higher (P<0.05) at 2 weeks on indigenous Ready-to-use Therapeutic Food (Medical Nutrition Therapy) (5.63 g/kg/day) as compared to Standard Nutrition Therapy (3.43 g/kg/day). 61.2% subjects achieved target weight compared to 47.7% controls. At 8 weeks, 82.8% subjects recovered from Severe Acute Malnutrition compared to 19.3% controls (P<0.005). The results obtained in community were comparable to facility-based indigenous Ready-to-use Therapeutic Food (Medical Nutrition Therapy). The morbidity was less in study group at follow-up. CONCLUSIONS: Indigenous Ready-to-use Therapeutic Food (Medical Nutrition Therapy) appeared to be superior to Standard Nutrition Therapy in promoting weight gain in children with Severe Acute Malnutrition.