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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 : Recruiting
First Posted : March 29, 2017
Last Update Posted : May 7, 2018
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

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.

Condition or disease Intervention/treatment Phase
Severe Acute Malnutrition Drug: Amoxicillin Dietary Supplement: HO-RUTF Dietary Supplement: D-HO-RUTF Dietary Supplement: C-RUTF Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improved Polyunsaturated Ready-to-use Therapeutic Food for Improved Neurocognitive Outcomes in Severe Acute Malnutrition
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Active Comparator: Conventional RUTF (C-RUTF)
This is the control group for the study, which will receive the international standard of care therapeutic food. C-RUTF is made with conventional peanuts, which are inherently high in omega-6 linoleic acid.
Drug: Amoxicillin
All patients with severe acute malnutrition will receive a course of amoxicillin.
Other Name: Amoxil

Dietary Supplement: C-RUTF
C-RUTF: Milk, linseed oil, palm oil, white sugar, standard peanuts

Experimental: High oleic RUTF (HO-RUTF)
The treatment provided to children randomized to this arm of the study includes nutritional content comparable to C-RUTF with the exception of a low lineoleic acid/high oleic acid ratio formulated with high oleic content peanuts.
Drug: Amoxicillin
All patients with severe acute malnutrition will receive a course of amoxicillin.
Other Name: Amoxil

Dietary Supplement: HO-RUTF
HO-RUTF: Milk, linseed oil, palm oil, white sugar, high oleic peanuts

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.
Drug: Amoxicillin
All patients with severe acute malnutrition will receive a course of amoxicillin.
Other Name: Amoxil

Dietary Supplement: D-HO-RUTF
D-HO-RUTF: DHA, milk, linseed oil, palm oil, white sugar, high oleic peanuts




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Neurocognitive outcome [ Time Frame: Upon nutritional recovery obtained at 4-12 weeks ]
    Defined by Willatts intention score adapted for field training

  2. 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

  3. Attentional orienting speed [ Time Frame: Upon nutritional recovery obtained at 4-12 weeks ]
    Measured by mean saccade latency to peripheral targets

  4. 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

  5. Neurocognitive outcome [ Time Frame: Upon nutritional recovery at 3 years of age ]
    Measured by score on the Malawian Developmental Assessment Test (MDAT)



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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094247


Contacts
Contact: Mark J Manary, MD +1 314 454 2341 manary@kids.wustl.edu
Contact: Kenneth Maleta, MBBS +256 018 719 111 ken.maleta@gmail.com

Locations
Malawi
University of Malawi College of Medicine Recruiting
Blantyre, Malawi
Contact: Kenneth Maleta, MBBS    +256 018 719 111    ken.maleta@gmail.com   
Principal Investigator: Kenneth Maleta, MBBS         
Sub-Investigator: Chrissie Thawalawka, PhD         
Sponsors and Collaborators
Washington University School of Medicine
University of Texas at Austin
Cornell University
University of Malawi College of Medicine
Investigators
Study Chair: Mark J Manary, MD Washington University School of Medicine

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03094247     History of Changes
Other Study ID Numbers: MMPUFA17
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:
Malnutrition
Micronutrients
Polyunsaturated fatty acids
Ready-to-use therapeutic foods
Omega-3 fatty acids
Peanuts

Additional relevant MeSH terms:
Malnutrition
Severe Acute Malnutrition
Nutrition Disorders
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents