Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition

Kwashiorkor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053857
• Other study ID #: PUFA-RUTF Pilot
• Status: Completed
• Phase: N/A
• First received: January 31, 2014
• Last updated: September 26, 2014
• Start date: February 2014
• Est. completion date: July 2014

Study information

• Verified date: September 2014
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kwashiorkor
• Malnutrition
• Marasmus

Intervention

Dietary Supplement:
• RUTF

• RUTF-P

Drug:
• Amoxicillin

Locations

Country	Name	City	State
Malawi	University of Malawi College of Medicine	Blantyre

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	University of Malawi

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DHA Level	Blood plasma docosahexaenoic acid (DHA) levels	4 weeks	No
Primary	EPA Level	Blood plasma eicosapentaenoic acid (EPA) levels	4 weeks	No
Secondary	Recovery Rate	Proportion of children who recover from SAM	12 weeks	No
Secondary	Linear Growth	Changes in length	12 weeks	No
Secondary	Ponderal Growth	Changes in weight	12 weeks	No
Secondary	Growth	Changes in mid-upper-arm circumference	12 weeks	No