Alka Rajendra Jadhav1, Prachi Karnik2, Lavina Fernandes1, Sneha Fernandes1, Narendra Shah3, Mamta Manglani1. 1. Department of Pediatrics, Lokmanya Tilak Municipal Medical College and General Hospital, Mumbai, Maharashtra, India. 2. Department of Pediatrics, Lokmanya Tilak Municipal Medical College and General Hospital, Mumbai, Maharashtra, India. Correspondence to: Dr Prachi Karnik, Assistant Professor, Department of Pediatrics, Lokmanya Tilak Municipal Medical College and General Hospital, Sion, Mumbai, Maharashtra 400 022, India. drprachi.sk@gmail.com. 3. Centre for Technology Alternatives for Rural Areas, Indian Institute of Technology; Mumbai, Maharashtra, India.
Abstract
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.
RCT Entities:
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.