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Trial record 1 of 1 for:    NCT03094247
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Feeding Malnourished Children Different Types of Fatty Acids to Promote Neurocognitive Development

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ClinicalTrials.gov Identifier: NCT03094247
Recruitment Status : Completed
First Posted : March 29, 2017
Last Update Posted : July 15, 2021
Sponsor:
Collaborators:
University of Texas at Austin
Cornell University
University of Malawi College of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE March 23, 2017
First Posted Date  ICMJE March 29, 2017
Last Update Posted Date July 15, 2021
Actual Study Start Date  ICMJE October 2, 2017
Actual Primary Completion Date March 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2021)
  • Neurocognitive outcome [ Time Frame: Time Frame: 4 to 7 months after nutritional outcome ]
    Measured by score on the Malawian Developmental Assessment Test (MDAT). The scale is continuous and interval in nature, the range varies by population
    • The scale title is "Malawi Developmental Assessment Tool z-score"
    • The primary outcome is Global z-score, titled "Global z-sore"
    • Secondary outcomes are 4 sub-domain z-scores are titled "Gross motor z-score", "Fine motor z-score", Language z-score", and "Social z-score"
  • Neurocognitive outcome [ Time Frame: Time Frame: within 4 weeks after nutritional outcome ]
    Defined by Willatts intention score adapted for field training, 3 problems to be tested. The scale is ordinal in nature, with higher values indicated better scores
    • The scale title is "Intention Score"
    • Problem 1 is scored 0 - 4
    • Problem 2 is scored 0 - 4
    • Problem 3 is scored 0 - 8
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2017)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2021)
  • 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
  • Attentional orienting speed [ Time Frame: 4-7 months after nutritional after nutritional outcome ]
    Measured by mean saccade latency to peripheral targets
  • Adverse Events [ Time Frame: Fortnightly follow up visits up to 12 weeks following enrollment ]
    Measured by number of days diarrhea and/or rashes.
  • Acceptance of RUTF [ Time Frame: Fortnightly follow up visits up to 12 weeks following enrollment ]
    Mother's report of if the child ate the food well. This is a yes or no question.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2017)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feeding Malnourished Children Different Types of Fatty Acids to Promote Neurocognitive Development
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Severe Acute Malnutrition
Intervention  ICMJE
  • Drug: Amoxicillin
    All patients with severe acute malnutrition will receive a course of amoxicillin.
    Other Name: Amoxil
  • Dietary Supplement: HO-RUTF
    HO-RUTF: Milk, perilla oil, palm oil, white sugar, high oleic peanuts
  • Dietary Supplement: D-HO-RUTF
    D-HO-RUTF: DHA, milk, perilla oil, palm oil, white sugar, high oleic peanuts
  • Dietary Supplement: S-RUTF
    S-RUTF: Milk, canola oil, palm oil, white sugar, standard peanuts
Study Arms  ICMJE
  • Active Comparator: Conventional RUTF (S-RUTF)
    This is the control group for the study, which will receive the international standard of care therapeutic food. S-RUTF is made with conventional peanuts, which are inherently high in omega-6 linoleic acid.
    Interventions:
    • Drug: Amoxicillin
    • Dietary Supplement: S-RUTF
  • Experimental: High oleic RUTF (HO-RUTF)
    The treatment provided to children randomized to this arm of the study includes nutritional content comparable to S-RUTF with the exception of a low lineoleic acid/high oleic acid ratio formulated with high oleic content peanuts.
    Interventions:
    • Drug: Amoxicillin
    • Dietary Supplement: HO-RUTF
  • Experimental: DHA-supplemented HO-RUTF (D-HO-RUTF)
    The treatment provided to children randomized to this arm of the study mirrors that provided by HO-RUTF with that addition of supplemental DHA at a level higher than attainable with optimal precursors.
    Interventions:
    • Drug: Amoxicillin
    • Dietary Supplement: D-HO-RUTF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2021)
2897
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2017)
3700
Actual Study Completion Date  ICMJE March 23, 2021
Actual Primary Completion Date March 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 6-59 months
  • An acceptable appetite defined by the ability to consume 30 grams RUTF within 20 minutes
  • Mid Upper Arm Circumference <11.5 cm, weight-for-height z-score < -3, or bilateral pitting edema on the dorsum of the feet

Exclusion Criteria:

  • Participation in any other ongoing study or supplementary feeding program
  • Children with a chronic medical condition, including cerebral palsy, static encephalopathy, congenital heart disease, gastrointestinal disease, or peanut allergy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 59 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malawi
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03094247
Other Study ID Numbers  ICMJE MMPUFA17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE
  • University of Texas at Austin
  • Cornell University
  • University of Malawi College of Medicine
Investigators  ICMJE
Study Chair: Mark J Manary, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP