To test whether a ready-to-use therapeutic food (RUTF) enriched with polyunsaturated fatty acids (RUTF-P) is as effective for the treatment of severe acute malnutrition (SAM) as standard RUTF.
Since 2007, RUTF has been the recommended treatment for SAM. RUTF is not conducive to the growth of bacteria because of the low moisture content, does not require cooking, and has led to greater recovery rates than liquid milk formulations in direct comparisons. One expected benefit of the RUTF-P is improved outcomes due to the higher levels of essential fatty acids. The essential fatty acid profile (i.e., the level of omega-3 and omega-6 fatty acids) of RUTF-P may have important implications for cognitive development of children, especially infants, with SAM who consume these foods as their sole dietary source for several weeks. In particular, an excess of omega-6 fatty acids (from sources such as peanut and corn oil) and a minimum of omega-3 fatty acids (from sources like flax) may fail to support optimal cognitive development and neural function. In this prospective, double-blinded, randomized controlled clinical effectiveness trial, we will compare two RUTF products in the treatment of SAM to test the effects of the two different RUTF products on essential fatty acid status.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
141
University of Malawi College of Medicine
Blantyre, Malawi
DHA Level
Blood plasma docosahexaenoic acid (DHA) levels
Time frame: 4 weeks
EPA Level
Blood plasma eicosapentaenoic acid (EPA) levels
Time frame: 4 weeks
Recovery Rate
Proportion of children who recover from SAM
Time frame: 12 weeks
Linear Growth
Changes in length
Time frame: 12 weeks
Ponderal Growth
Changes in weight
Time frame: 12 weeks
Growth
Changes in mid-upper-arm circumference
Time frame: 12 weeks
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