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Completed

NCT Number: NCT02053857

Pilot Study of PUFA-optimized RUTF for 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.

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Key information

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Malawi College of Medicine

Blantyre, Malawi

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RUTF

Dietary Supplement

Other names: ready-to-use therapeutic food

RUTF-P

Dietary Supplement

Amoxicillin

Drug

Primary outcomes

  1. DHA Level

    Time frame: 4 weeks

    Blood plasma docosahexaenoic acid (DHA) levels

  2. EPA Level

    Time frame: 4 weeks

    Blood plasma eicosapentaenoic acid (EPA) levels

Secondary outcomes

  1. Recovery Rate

    Time frame: 12 weeks

    Proportion of children who recover from SAM

  2. Linear Growth

    Time frame: 12 weeks

    Changes in length

  3. Ponderal Growth

    Time frame: 12 weeks

    Changes in weight

  4. Growth

    Time frame: 12 weeks

    Changes in mid-upper-arm circumference

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • University of Malawi

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 4, 2014
Registry last updated
Sep 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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