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Completed

NCT Number: NCT03094247

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

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.

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Key information

Conditions

Severe Acute Malnutrition Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Malawi College of Medicine

Blantyre, Malawi

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amoxicillin

Drug

All patients with severe acute malnutrition will receive a course of amoxicillin.

Other names: Amoxil

HO-RUTF

Dietary Supplement

HO-RUTF: Milk, perilla oil, palm oil, white sugar, high oleic peanuts

D-HO-RUTF

Dietary Supplement

D-HO-RUTF: DHA, milk, perilla oil, palm oil, white sugar, high oleic peanuts

S-RUTF

Dietary Supplement

S-RUTF: Milk, canola oil, palm oil, white sugar, standard peanuts

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Cornell University
  • Kamuzu University of Health Sciences
  • University of Texas at Austin

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 29, 2017
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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