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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03094247

Enrollment

2897

Registered

2017-03-29

Start date

2017-10-02

Completion date

2021-03-23

Last updated

2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Acute Malnutrition

Keywords

Malnutrition, Micronutrients, Polyunsaturated fatty acids, Ready-to-use therapeutic foods, Omega-3 fatty acids, Peanuts

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.

Interventions

DRUGAmoxicillin

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

DIETARY_SUPPLEMENTHO-RUTF

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

DIETARY_SUPPLEMENTD-HO-RUTF

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

DIETARY_SUPPLEMENTS-RUTF

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 59 Months

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

Design outcomes

Primary

Measure	Time frame	Description
Neurocognitive outcome	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

Secondary

Measure	Time frame	Description
Attentional orienting speed	4-7 months after nutritional after nutritional outcome	Measured by mean saccade latency to peripheral targets
Adverse Events	Fortnightly follow up visits up to 12 weeks following enrollment	Measured by number of days diarrhea and/or rashes.
Nutritional recovery	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
Acceptance of RUTF	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.

Countries

Malawi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026