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

Severe Acute Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03094247
• Other study ID #: MMPUFA17
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: March 23, 2021

Study information

• Verified date: July 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2897
• Est. completion date: March 23, 2021
• Est. primary completion date: March 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Severe Acute Malnutrition

Intervention

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

Dietary Supplement:
• HO-RUTF
HO-RUTF: Milk, perilla oil, palm oil, white sugar, high oleic peanuts
• D-HO-RUTF
D-HO-RUTF: DHA, milk, perilla oil, palm oil, white sugar, high oleic peanuts
• S-RUTF
S-RUTF: Milk, canola oil, palm oil, white sugar, standard peanuts

Locations

Country	Name	City	State
Malawi	University of Malawi College of Medicine	Blantyre

Sponsors (4)

Lead Sponsor	Collaborator
Washington University School of Medicine	Cornell University, University of Malawi College of Medicine, University of Texas at Austin

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"	Time Frame: 4 to 7 months after nutritional outcome
Primary	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	Time Frame: within 4 weeks after nutritional outcome
Secondary	Nutritional recovery	Defined by resolution of edema AND mid-upper arm circumference [MUAC] >12.4cm, AND/OR a weight/height z-score [WHZ] >-3	Up to 12 weeks following enrollment
Secondary	Attentional orienting speed	Measured by mean saccade latency to peripheral targets	4-7 months after nutritional after nutritional outcome
Secondary	Adverse Events	Measured by number of days diarrhea and/or rashes.	Fortnightly follow up visits up to 12 weeks following enrollment
Secondary	Acceptance of RUTF	Mother's report of if the child ate the food well. This is a yes or no question.	Fortnightly follow up visits up to 12 weeks following enrollment