Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition

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

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.

Study Overview

• Status: Completed
• Conditions: Kwashiorkor; Marasmus
• Intervention / Treatment: Drug: Amoxicillin; Dietary supplement: RUTF; Dietary supplement: RUTF-P

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 Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Blantyre, Malawi
    • University of Malawi College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: University of Malawi
• Investigators: Principal Investigator: Kenneth Maleta, MBBS PhD, University of Malawi; Principal Investigator: Chrissie Thakwalakwa, University of Malawi

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: January 31, 2014
• First Submitted That Met QC Criteria: January 31, 2014
• First Posted (Estimate): February 4, 2014

Study Record Updates

• Last Update Posted (Estimate): September 29, 2014
• Last Update Submitted That Met QC Criteria: September 26, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: severe acute malnutrition; polyunsaturated fatty acids; ready-to-use therapeutic food
• Additional Relevant MeSH Terms: Nutrition Disorders; Deficiency Diseases; Protein Deficiency; Malnutrition; Severe Acute Malnutrition; Protein-Energy Malnutrition; Kwashiorkor; Anti-Infective Agents; Anti-Bacterial Agents; Amoxicillin
• Other Study ID Numbers: PUFA-RUTF Pilot