Kwashiorkor, Marasmus
Conditions
Keywords
severe acute malnutrition, polyunsaturated fatty acids, ready-to-use therapeutic food
Brief summary
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
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.
Interventions
Sponsors
University of Malawi
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DHA Level | 4 weeks | Blood plasma docosahexaenoic acid (DHA) levels |
| EPA Level | 4 weeks | Blood plasma eicosapentaenoic acid (EPA) levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery Rate | 12 weeks | Proportion of children who recover from SAM |
| Linear Growth | 12 weeks | Changes in length |
| Ponderal Growth | 12 weeks | Changes in weight |
| Growth | 12 weeks | Changes in mid-upper-arm circumference |
Countries
Malawi
Outcome results
None listed