Effectiveness, Tolerability and Safety of Three Formulations in Underfives With Moderate Acute Malnutrition

Childhood malnutrition is presently a leading cause of underfive morbidity and mortality globally. The impact of the condition is most severe in the first 1000 days of life with resultant impairment in physical, neurologic, immunologic and metabolic development. Undernutrition, the commoner form of childhood malnutrition, is usually classified as underweight (weight-for-age Z score \< -2), stunting (height-for-age Z score \<-2), wasting (weight-for-height Z score \< -2) or edematous malnutrition (kwashiorkor) in relation to the World Health Organization standard reference values for age and sex. It is further sub-classified into severe acute malnutrition (SAM) wherein z score is \<-3 and moderate acute malnutrition (MAM) wherein z score is between -2 and -3.(1) MAM accounts for about 70.0% of all malnutrition-related childhood deaths. Children with MAM are currently managed using community-based approach. This approach entails early detection and treatment of children with MAM in the community, timely referral to inpatient care for those that progress to SAM or develop complications, and subsequent follow up in the community at discharge. MAM is usually managed by nutrition education of the caregivers on preparation of nutritious, palatable and culturally acceptable food from locally available food stuffs like banana porridge or corn gruel fortified with legume (mashed groundnut or soya bean), crayfish, palm oil, powdered milk and vegetables. The second strategy is by Ready-to-use therapeutic foods (RUTFs). (2) The main drawback of the RUTFs is that they are usually provided by external donor agencies and as such, not always available in settings where childhood malnutrition is endemic. Children treated with RUTFs are therefore at risk of progressing to SAM or dying when the formulations are no longer available. There is currently no consensus on the appropriate nutritional formulation for community-based management of MAM in children in endemic regions. It is therefore imperative to evaluate the effect of readily available formulations that are comparable to the RUTFs in community-based management of childhood MAM in endemic regions. (3) The standardized milk-based formulation (SMBF), the standardized non milk-based formulation (SNMBF) and the hospital-based formulation (HBF) are examples of formulations that are readily available in the country. The SMBF consists of maize and is rich in methionine, the SNMBF consists of maize and soybeans, and is rich in methionine and lysine while the HBF consist of a combination of maize, milk and soybeans. The nutrient composition of the above-mentioned formulations is similar to that of the RUTFs, making them suitable for community-based management of MAM. However, no clinical trial has so far been conducted to evaluate their effect in managing underfive children with MAM. The cost effectiveness of the various formulations will also be assessed.