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| Name | Class |
|---|---|
| University of Malawi | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RUTF | Active Comparator | Standard RUTF at a dose of 175 kcal/kg/d |
|
| RUTF-P | Experimental | RUTF fortified with polyunsaturated fatty acids (PUFA) at a dose of 175 kcal/kg/d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RUTF | Dietary Supplement |
|
| |
| RUTF-P |
| Measure | Description | Time Frame |
|---|---|---|
| DHA Level | Blood plasma docosahexaenoic acid (DHA) levels | 4 weeks |
| EPA Level | Blood plasma eicosapentaenoic acid (EPA) levels | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery Rate | Proportion of children who recover from SAM | 12 weeks |
| Linear Growth | Changes in length | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark J Manary, MD | Washington University School of Medicine | Principal Investigator |
| Kenneth Maleta, MBBS PhD | University of Malawi | Principal Investigator |
| Chrissie Thakwalakwa | University of Malawi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Malawi College of Medicine | Blantyre | Malawi |
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| ID | Term |
|---|---|
| D007732 | Kwashiorkor |
| D011502 | Protein-Energy Malnutrition |
| D000067011 | Severe Acute Malnutrition |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011488 | Protein Deficiency |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Dietary Supplement |
|
| Amoxicillin | Drug |
|
| Ponderal Growth | Changes in weight | 12 weeks |
| Growth | Changes in mid-upper-arm circumference | 12 weeks |
| D003677 |
| Deficiency Diseases |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |