Malnutrition Clinical Trial
Official title:
Randomized Controlled Trial of an Outpatient Strategy of Ready to Use Supplementary Food (RUSF) Among Moderately Malnourished Children With Acute Infection
The purpose of this study is to determine whether an outpatient-based strategy of short-term, ready to use supplementary food (RUSF) among moderately malnourished children with acute infections achieves greater improvement in anthropometric measurements of wasting than usual diet.
Under nutrition is a contributing factor to at least a third of child deaths. Whilst severe
malnutrition has the highest mortality risk, most malnutrition-related deaths are thought to
be related to mild-moderate malnutrition.This is because moderate malnutrition is common, it
directly increases the risk of death from common infectious diseases and may progress to
severe malnutrition.
Malnutrition may arise from poverty, food insecurity or inadequate nutrition being offered,
and may begin early in life. Malnutrition is exacerbated by the multiple effects of
infectious diseases such as gastroenteritis, pneumonia, malaria or HIV. All these common
infections are associated with net protein loss with diversion of essential amino acids to
producing acute phase and immune response proteins. Fever is associated with an increased
resting energy expenditure of 7 to 13% per degree Centigrade. Activation of inflammatory
cascades also causes reduced appetite and loss of lean tissue and fat. Acute infection is
therefore associated with growth faltering, resulting in a vicious cycle. Acute infection is
therefore a potential target for intervention to interrupt the vicious cycle between
malnutrition and infection in children.
This study aims to evaluate a strategy of giving short-term RUSF as a supplement to usual
diet at home, without daily observed feeding, administered through existing health services
at Kilifi District Hospital, Kenya. RUSF has a very low moisture content and is essentially
a lipid-enveloped paste, it is microbiologically stable with a long shelf life at tropical
temperatures and preserves delicate micronutrients such as vitamin A.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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