University of Malawi College of Medicine
Blantyre, Malawi
NCT Number: NCT02053857
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.
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Notify Me6 month–59 month
All sexes
Interventional
Not applicable
Blantyre, Malawi
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: ready-to-use therapeutic food
Time frame: 4 weeks
Blood plasma docosahexaenoic acid (DHA) levels
Time frame: 4 weeks
Blood plasma eicosapentaenoic acid (EPA) levels
Time frame: 12 weeks
Proportion of children who recover from SAM
Time frame: 12 weeks
Changes in length
Time frame: 12 weeks
Changes in weight
Time frame: 12 weeks
Changes in mid-upper-arm circumference
Washington University School of Medicine
Other
A Randomized, Double-blind Pilot Study of Polyunsaturated Fatty Acid-optimized Ready-to-use Therapeutic Food, Compared to Standard RUTF, in the Therapy of Severe Acute Malnutrition
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