Clinical Trial: Feeding Malnourished Children Different Types of Fatty Acids to Promote Neurocognitive Development

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Improved Polyunsaturated Ready-to-use Therapeutic Food for Improved Neurocognitive Outcomes in Severe Acute Malnutrition

Brief Summary: An appropriate balance of omega-6 and omega-3 fatty acids is important for support of neurocognitive development in healthy infants and toddlers. In young children recovering from severe acute malnutrition (SAM), excess omega-6 intake depletes omega-3 fatty acid status. This research will evaluate how novel ready-to-use therapeutic foods (RUTF) with balanced fatty acids improve the metabolic and neurocognitive effects in young children in Malawi recovering from SAM, yielding new knowledge that also has implications for development of well-nourished children.

Detailed Summary:
Sponsor: Washington University School of Medicine

Current Primary Outcome: Nutritional recovery [ Time Frame: Up to 12 weeks following enrollment ]

Defined by resolution of edema AND mid-upper arm circumference [MUAC] >12.4cm, AND/OR a weight/height z-score [WHZ] >3


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Neurocognitive outcome [ Time Frame: Upon nutritional recovery obtained at 4-12 weeks ]
    Defined by Willatts intention score adapted for field training
  • Recognition memory [ Time Frame: Upon nutritional recovery obtained at 4-12 weeks ]
    Measured by relational visual memory task as defined as overall percentage looking at match
  • Attentional orienting speed [ Time Frame: Upon nutritional recovery obtained at 4-12 weeks ]
    Measured by mean saccade latency to peripheral targets
  • Intentionality, planning, and attentional control tasks [ Time Frame: Upon nutritional recovery obtained at 4-12 weeks ]
    Measured by complex object retrieval, look duration, time spent in focused attention, passive inattention, and active inattention
  • Neurocognitive outcome [ Time Frame: Upon nutritional recovery at 3 years of age ]
    Measured by score on the Malawian Developmental Assessment Test (MDAT)


Original Secondary Outcome: Same as current

Information By: Washington University School of Medicine

Dates:
Date Received: March 23, 2017
Date Started: June 1, 2017
Date Completion: September 1, 2019
Last Updated: March 23, 2017
Last Verified: March 2017