Clinical Trial: Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Washington University School of Medicine

Current Primary Outcome:

  • DHA Level [ Time Frame: 4 weeks ]
    Blood plasma docosahexaenoic acid (DHA) levels
  • EPA Level [ Time Frame: 4 weeks ]
    Blood plasma eicosapentaenoic acid (EPA) levels


Original Primary Outcome: Fatty Acid Status [ Time Frame: 4 weeks ]

Blood plasma docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) levels


Current Secondary Outcome:

  • Recovery Rate [ Time Frame: 12 weeks ]
    Proportion of children who recover from SAM
  • Linear Growth [ Time Frame: 12 weeks ]
    Changes in length
  • Ponderal Growth [ Time Frame: 12 weeks ]
    Changes in weight
  • Growth [ Time Frame: 12 weeks ]
    Changes in mid-upper-arm circumference


Original Secondary Outcome: Growth [ Time Frame: 12 weeks ]

Changes in length, weight, mid-upper-arm circumference and resolution of SAM


Information By: Washington University School of Medicine

Dates:
Date Received: January 31, 2014
Date Started: February 2014
Date Completion:
Last Updated: September 26, 2014
Last Verified: September 2014