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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

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: S-RUTF Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2897 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 : October 2, 2017
Actual Primary Completion Date : March 23, 2021
Actual Study Completion Date : March 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

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

Dietary Supplement: S-RUTF
S-RUTF: Milk, canola 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 S-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, perilla 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, perilla oil, palm oil, white sugar, high oleic peanuts




Primary Outcome Measures :
  1. 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"

  2. 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


Secondary 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

  2. Attentional orienting speed [ Time Frame: 4-7 months after nutritional after nutritional outcome ]
    Measured by mean saccade latency to peripheral targets

  3. Adverse Events [ Time Frame: Fortnightly follow up visits up to 12 weeks following enrollment ]
    Measured by number of days diarrhea and/or rashes.

  4. 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.



Information from the National Library of Medicine

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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


Locations
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Malawi
University of Malawi College of Medicine
Blantyre, Malawi
Sponsors and Collaborators
Washington University School of Medicine
University of Texas at Austin
Cornell University
University of Malawi College of Medicine
Investigators
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Study Chair: Mark J Manary, MD Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03094247    
Other Study ID Numbers: MMPUFA17
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Malnutrition
Severe Acute Malnutrition
Nutrition Disorders
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents