Clinical trial NCT03094247: 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
Overall status: COMPLETED
Phase: NA
Conditions: Severe Acute Malnutrition
Keywords: Malnutrition
Micronutrients
Polyunsaturated fatty acids
Ready-to-use therapeutic foods
Omega-3 fatty acids
Peanuts
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Texas at Austin
name: Cornell University
name: Kamuzu University of Health Sciences
First posted: 2017-03-29
Enrollment: 2897
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Neurocognitive outcome
timeFrame: Time Frame: 4 to 7 months after nutritional outcome
measure: Neurocognitive outcome
timeFrame: Time Frame: within 4 weeks after nutritional outcome
Secondary outcomes:
measure: Nutritional recovery
timeFrame: Up to 12 weeks following enrollment
measure: Attentional orienting speed
timeFrame: 4-7 months after nutritional after nutritional outcome
measure: Adverse Events
timeFrame: Fortnightly follow up visits up to 12 weeks following enrollment
measure: Acceptance of RUTF
timeFrame: Fortnightly follow up visits up to 12 weeks following enrollment
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: University of Malawi College of Medicine
Study officials:
affiliation: Washington University School of Medicine
name: Mark J Manary, MD
role: STUDY_CHAIR
References:
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.