Effectiveness and tolerability of standardized milk based, standardized non-milk based and hospital-based formulations in the management of moderate acute malnutrition in under-five children: A randomized clinical trial

Abstract

Introduction : Moderate acute malnutrition (MAM) is a leading cause of under-five morbidity and mortality globally. Supplementary feeding is a strategy recommended by WHO for managing the condition.Objective: To evaluate the effectiveness and tolerability of standardized milk-based formulation (SMBF), standardized non-milk based formulation (SNMBF) and hospital-based formulation (HBF) in under-fives with MAM.Method: This was an open label randomized clinical trial in which eligible children aged 6 – 59 months with MAM were assigned to receive the SMBF, SNMBF or HBF at 50% of their daily caloric requirement with their regular family diet for four months. Their baseline characteristics and anthropometric indices were noted. They were followed up on two weekly basis during which further assessments were performed. The analysis for effectiveness and tolerability of the formulations were based on “per protocol”.Results: A total of 687 children were screened and 188 enrolled. Seventy children received SMBF, 63 received SNMBF while 55 received HBF. There were 54/70 (77.1%), 57/64 (89.1%) and 46/55 (83.6%) evaluable participants in the SMBF, SNMBF and HBF group respectively. Recovery from MAM was 43/54 (79.6%), 40/57 (70.2%) and 32/46 (69.6%) in the SMBF, SNMBF and HBF group respectively. Normal nutritional status was attained by 13 (24.0%), 10 (17.6%) and 5 (10.9%) children in the SMBF, SNMBF and HBF group respectively. Diarrhea and skin rashes were the main features of poor tolerability.Conclusions: The formulations were effective in managing MAM in childhood but the SMBF was the most effective. Diarrhea and skin rashes were the main features of poor tolerability.