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| Name | Class |
|---|---|
| University of Texas at Austin | OTHER |
| Cornell University | OTHER |
| Kamuzu University of Health Sciences | OTHER |
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An appropriate balance of omega-6 and omega-3 fatty acids is important for support of neurocognitive development in healthy infants and toddlers. In young children recovering from severe acute malnutrition (SAM), excess omega-6 intake depletes omega-3 fatty acid status. This research will evaluate how novel ready-to-use therapeutic foods (RUTF) with balanced fatty acids improve the metabolic and neurocognitive effects in young children in Malawi recovering from SAM, yielding new knowledge that also has implications for development of well-nourished children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional RUTF (S-RUTF) | Active Comparator | This is the control group for the study, which will receive the international standard of care therapeutic food. S-RUTF is made with conventional peanuts, which are inherently high in omega-6 linoleic acid. |
|
| High oleic RUTF (HO-RUTF) | Experimental | The treatment provided to children randomized to this arm of the study includes nutritional content comparable to S-RUTF with the exception of a low lineoleic acid/high oleic acid ratio formulated with high oleic content peanuts. |
|
| DHA-supplemented HO-RUTF (D-HO-RUTF) | Experimental | The treatment provided to children randomized to this arm of the study mirrors that provided by HO-RUTF with that addition of supplemental DHA at a level higher than attainable with optimal precursors. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin | Drug | All patients with severe acute malnutrition will receive a course of amoxicillin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive outcome | Measured by score on the Malawian Developmental Assessment Test (MDAT). The scale is continuous and interval in nature, the range varies by population
| Time Frame: 4 to 7 months after nutritional outcome |
| Neurocognitive outcome | Defined by Willatts intention score adapted for field training, 3 problems to be tested. The scale is ordinal in nature, with higher values indicated better scores
| Time Frame: within 4 weeks after nutritional outcome |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional recovery | Defined by resolution of edema AND mid-upper arm circumference [MUAC] >12.4cm, AND/OR a weight/height z-score [WHZ] >-3 | Up to 12 weeks following enrollment |
| Attentional orienting speed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark J Manary, MD | Washington University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Malawi College of Medicine | Blantyre | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34726694 | Derived | Stephenson K, Callaghan-Gillespie M, Maleta K, Nkhoma M, George M, Park HG, Lee R, Humphries-Cuff I, Lacombe RJS, Wegner DR, Canfield RL, Brenna JT, Manary MJ. Low linoleic acid foods with added DHA given to Malawian children with severe acute malnutrition improve cognition: a randomized, triple-blinded, controlled clinical trial. Am J Clin Nutr. 2022 May 1;115(5):1322-1333. doi: 10.1093/ajcn/nqab363. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
Individual participant data that underlie the results reported in the article after deidentification will be indefinitely available within 9 months following article publication through The Washington University Open Scholarship Institutional Repository.
Data will be available within 9 months of article publication. Data will remain available indefinitely.
Anyone who wishes to access the data.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 16, 2021 | Jul 13, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000067011 | Severe Acute Malnutrition |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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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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|
| HO-RUTF | Dietary Supplement | HO-RUTF: Milk, perilla oil, palm oil, white sugar, high oleic peanuts |
|
| D-HO-RUTF | Dietary Supplement | D-HO-RUTF: DHA, milk, perilla oil, palm oil, white sugar, high oleic peanuts |
|
| S-RUTF | Dietary Supplement | S-RUTF: Milk, canola oil, palm oil, white sugar, standard peanuts |
|
Measured by mean saccade latency to peripheral targets
| 4-7 months after nutritional after nutritional outcome |
| Adverse Events | Measured by number of days diarrhea and/or rashes. | Fortnightly follow up visits up to 12 weeks following enrollment |
| Acceptance of RUTF | Mother's report of if the child ate the food well. This is a yes or no question. | Fortnightly follow up visits up to 12 weeks following enrollment |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |