Clinical trial NCT02053857: Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kwashiorkor
Marasmus
Keywords: severe acute malnutrition
polyunsaturated fatty acids
ready-to-use therapeutic food
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Malawi
First posted: 2014-02-04
Enrollment: 141
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: DHA Level
timeFrame: 4 weeks
measure: EPA Level
timeFrame: 4 weeks
Secondary outcomes:
measure: Recovery Rate
timeFrame: 12 weeks
measure: Linear Growth
timeFrame: 12 weeks
measure: Ponderal Growth
timeFrame: 12 weeks
measure: Growth
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: University of Malawi College of Medicine
Study officials:
affiliation: Washington University School of Medicine
name: Mark J Manary, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malawi
name: Kenneth Maleta, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malawi
name: Chrissie Thakwalakwa
role: PRINCIPAL_INVESTIGATOR
References: