Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Kwashiorkor, Marasmus

Intervention / Treatment
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* Dietary Supplement: RUTF
* Dietary Supplement: RUTF-P
* Drug: Amoxicillin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: kwashiorkor and/or marasmus 6-59 months of age lives in local area near enrollment site Exclusion Criteria: recent (<4 months) therapeutic feeding for moderate or severe acute malnutrition chronic medical condition (eg, Down syndrome, other congenital syndrome, chronic heart disease) that may make feeding and growth difficult (not to include HIV or TB) caretaker refusal of 2 blood draws ineligibility for outpatient therapy (ie, severe illness or anorexia requiring inpatient therapy) caretaker expresses plans to move away from local area of clinic, making followup difficult

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RUTF<br>Standard RUTF at a dose of 175 kcal/kg/d | Dietary Supplement: RUTF<br> <br> * Other names: ready-to-use therapeutic food;Drug: Amoxicillin<br> <br> |
| Experimental: RUTF-P<br>RUTF fortified with polyunsaturated fatty acids (PUFA) at a dose of 175 kcal/kg/d | Dietary Supplement: RUTF-P<br> <br> Drug: Amoxicillin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DHA Level | Blood plasma docosahexaenoic acid (DHA) levels | 4 weeks | 
| EPA Level | Blood plasma eicosapentaenoic acid (EPA) levels | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery Rate | Proportion of children who recover from SAM | 12 weeks | 
| Linear Growth | Changes in length | 12 weeks | 
| Ponderal Growth | Changes in weight | 12 weeks | 
| Growth | Changes in mid-upper-arm circumference | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe acute malnutrition, polyunsaturated fatty acids, ready-to-use therapeutic food