Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition

NCT ID: NCT02053857

Last Updated: 2014-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-07-31

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.

Conditions

Kwashiorkor; Marasmus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

RUTF

Standard RUTF at a dose of 175 kcal/kg/d

Group Type: ACTIVE_COMPARATOR

RUTF

Intervention Type: DIETARY_SUPPLEMENT

Amoxicillin

Intervention Type: DRUG

RUTF-P

RUTF fortified with polyunsaturated fatty acids (PUFA) at a dose of 175 kcal/kg/d

Group Type: EXPERIMENTAL

RUTF-P

Intervention Type: DIETARY_SUPPLEMENT

Amoxicillin

Intervention Type: DRUG

Interventions

RUTF

Intervention Type: DIETARY_SUPPLEMENT

RUTF-P

Intervention Type: DIETARY_SUPPLEMENT

Amoxicillin

Intervention Type: DRUG

Other Intervention Names

ready-to-use therapeutic food

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malawi

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark J Manary, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Kenneth Maleta, MBBS PhD

Role: PRINCIPAL_INVESTIGATOR

University of Malawi

Chrissie Thakwalakwa

Role: PRINCIPAL_INVESTIGATOR

University of Malawi

Locations

University of Malawi College of Medicine

Blantyre, , Malawi

Countries

Malawi

Other Identifiers

PUFA-RUTF Pilot

Identifier Type: -

Identifier Source: org_study_id