Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition

The Washington University

Status: Completed

Conditions: Kwashiorkor; Marasmus

Treatments: Drug: Amoxicillin; Dietary Supplement: RUTF-P; Dietary Supplement: RUTF

Study type: Interventional

Funder types: Other

Identifiers

NCT02053857

PUFA-RUTF Pilot

Details and patient eligibility

About

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.

Full 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.

Enrollment: 141 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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141 participants in 2 patient groups

RUTF

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: RUTF

Drug: Amoxicillin

RUTF-P

Experimental group

Description:

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

Treatment:

Drug: Amoxicillin

Dietary Supplement: RUTF-P