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

Primary Purpose

Severe Acute Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Amoxicillin
HO-RUTF
D-HO-RUTF
S-RUTF
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Acute Malnutrition focused on measuring Malnutrition, Micronutrients, Polyunsaturated fatty acids, Ready-to-use therapeutic foods, Omega-3 fatty acids, Peanuts

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Malawi College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Conventional RUTF (S-RUTF)

High oleic RUTF (HO-RUTF)

DHA-supplemented HO-RUTF (D-HO-RUTF)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Neurocognitive 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
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

Nutritional recovery
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
Measured by mean saccade latency to peripheral targets
Adverse Events
Measured by number of days diarrhea and/or rashes.
Acceptance of RUTF
Mother's report of if the child ate the food well. This is a yes or no question.

Full Information

First Posted
March 23, 2017
Last Updated
July 14, 2022
Sponsor
Washington University School of Medicine
Collaborators
University of Texas at Austin, Cornell University, Kamuzu University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03094247
Brief Title
Feeding Malnourished Children Different Types of Fatty Acids to Promote Neurocognitive Development
Official Title
Improved Polyunsaturated Ready-to-use Therapeutic Food for Improved Neurocognitive Outcomes in Severe Acute Malnutrition
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
March 23, 2021 (Actual)
Study Completion Date
March 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
University of Texas at Austin, Cornell University, Kamuzu University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Malnutrition
Keywords
Malnutrition, Micronutrients, Polyunsaturated fatty acids, Ready-to-use therapeutic foods, Omega-3 fatty acids, Peanuts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2897 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional RUTF (S-RUTF)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High oleic RUTF (HO-RUTF)
Arm Type
Experimental
Arm Description
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.
Arm Title
DHA-supplemented HO-RUTF (D-HO-RUTF)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Other Intervention Name(s)
Amoxil
Intervention Description
All patients with severe acute malnutrition will receive a course of amoxicillin.
Intervention Type
Dietary Supplement
Intervention Name(s)
HO-RUTF
Intervention Description
HO-RUTF: Milk, perilla oil, palm oil, white sugar, high oleic peanuts
Intervention Type
Dietary Supplement
Intervention Name(s)
D-HO-RUTF
Intervention Description
D-HO-RUTF: DHA, milk, perilla oil, palm oil, white sugar, high oleic peanuts
Intervention Type
Dietary Supplement
Intervention Name(s)
S-RUTF
Intervention Description
S-RUTF: Milk, canola oil, palm oil, white sugar, standard peanuts
Primary Outcome Measure Information:
Title
Neurocognitive outcome
Description
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"
Time Frame
Time Frame: 4 to 7 months after nutritional outcome
Title
Neurocognitive outcome
Description
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
Time Frame
Time Frame: within 4 weeks after nutritional outcome
Secondary Outcome Measure Information:
Title
Nutritional recovery
Description
Defined by resolution of edema AND mid-upper arm circumference [MUAC] >12.4cm, AND/OR a weight/height z-score [WHZ] >-3
Time Frame
Up to 12 weeks following enrollment
Title
Attentional orienting speed
Description
Measured by mean saccade latency to peripheral targets
Time Frame
4-7 months after nutritional after nutritional outcome
Title
Adverse Events
Description
Measured by number of days diarrhea and/or rashes.
Time Frame
Fortnightly follow up visits up to 12 weeks following enrollment
Title
Acceptance of RUTF
Description
Mother's report of if the child ate the food well. This is a yes or no question.
Time Frame
Fortnightly follow up visits up to 12 weeks following enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J Manary, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
University of Malawi College of Medicine
City
Blantyre
Country
Malawi

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in the article after deidentification will be indefinitely available within 9 months following article publication through The Washington University Open Scholarship Institutional Repository.
IPD Sharing Time Frame
Data will be available within 9 months of article publication. Data will remain available indefinitely.
IPD Sharing Access Criteria
Anyone who wishes to access the data.
IPD Sharing URL
https://openscholarship.wustl.edu/data/101/
Citations:
PubMed Identifier
34726694
Citation
Stephenson K, Callaghan-Gillespie M, Maleta K, Nkhoma M, George M, Park HG, Lee R, Humphries-Cuff I, Lacombe RJS, Wegner DR, Canfield RL, Brenna JT, Manary MJ. Low linoleic acid foods with added DHA given to Malawian children with severe acute malnutrition improve cognition: a randomized, triple-blinded, controlled clinical trial. Am J Clin Nutr. 2022 May 1;115(5):1322-1333. doi: 10.1093/ajcn/nqab363. Erratum In: Am J Clin Nutr. 2022 May 1;115(5):1442.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://openscholarship.wustl.edu/data/101/

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

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