Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition

Not Applicable

Completed

• Conditions: Kwashiorkor; Marasmus
• Interventions: Dietary Supplement: RUTF; Dietary Supplement: RUTF-P; Drug: Amoxicillin

• Registration Number: NCT02053857
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study First Submitted: 2014-01-31
• Study First Submitted QC: 2014-01-31
• Study Start: 2014-02
• Study First Posted: 2014-02-04
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-26
• Last Update Posted: 2014-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RUTF	RUTF	Standard RUTF at a dose of 175 kcal/kg/d
RUTF-P	RUTF-P	RUTF fortified with polyunsaturated fatty acids (PUFA) at a dose of 175 kcal/kg/d
RUTF	Amoxicillin	Standard RUTF at a dose of 175 kcal/kg/d
RUTF-P	Amoxicillin	RUTF fortified with polyunsaturated fatty acids (PUFA) at a dose of 175 kcal/kg/d

Primary Outcome Measures

Name	Time	Method
DHA Level	4 weeks	Blood plasma docosahexaenoic acid (DHA) levels
EPA Level	4 weeks	Blood plasma eicosapentaenoic acid (EPA) levels

Secondary Outcome Measures

Name	Time	Method
Growth	12 weeks	Changes in mid-upper-arm circumference
Linear Growth	12 weeks	Changes in length
Ponderal Growth	12 weeks	Changes in weight
Recovery Rate	12 weeks	Proportion of children who recover from SAM

Trial Locations

Locations (1)

University of Malawi College of Medicine; 🇲🇼 Blantyre, Malawi