Project Details

Emollient therapy for severe acute malnutrition: Randomized controlled clinical trial in Bangladesh

Gary Darmstadt, MD, MS

Summary

BACKGROUND: Severe acute malnutrition (SAM) affects an estimated 19 million children worldwide, and is estimated to cause about 1 million child deaths annually. GAP: Early and appropriate treatment for SAM – including provision of essential fatty acids (EFAs) – is essential to prevent progression to the stage of severe complications that can often be fatal. Limitations in the capacity of the diseased gastrointestinal system to absorb nutrients, however, often results in prolonged periods of rehabilitation of children with SAM. Despite global guidelines from WHO, scale-up of treatment for SAM in children is faltering. Current guidelines for management of SAM are complex and costly and recovery takes time. HYPOTHESIS: We hypothesize that topical applications of EFA-containing emollient – sunflower seed oil (SSO) – in children with SAM (under standard treatment for SAM) will result in improved skin barrier function, accelerated weight gain and clinical recovery compared to children with SAM under standard treatment alone. METHODS: The study is a randomized two-arm, controlled, unblinded, proof-of-concept clinical trial comparing standard-of-care for treatment of SAM to-standard-of-care plus topical emollient therapy with SSO 3 times daily. Our study population is children aged 2-24 months who are diagnosed with SAM and admitted to the icddr,b, Hospital in Dhaka, Bangladesh. RESULTS: Pending IMPACT: If emollient therapy is feasible for use and helps children with SAM recover faster, it is likely to improve cost-effectiveness and adoption of treatment at scale in hospitalized children with SAM. If this trial is successful in a controlled clinical environment, we would propose to further test the intervention in the treatment of children with SAM as well as with moderate acute malnutrition in the community, given the global trend toward community-based management of malnutrition whenever possible. Thus, topical emollient therapy has the potential to become a major public health intervention for reducing global child mortality and morbidity.