Effect of an Alternative RUTF on Intestinal Permeability in Children With Severe Acute Malnutrition

The Washington University

Status: Completed

Conditions: Malnutrition, Child

Treatments: Dietary Supplement: oat RUTF; Dietary Supplement: S-RUTF

Study type: Interventional

Funder types: Other

Identifiers

NCT04334538

202003153

Details and patient eligibility

About

Ready-to-use therapeutic food (RUTF) is the standard of care for the treatment of SAM. UNICEF requires that there be no oil separation in these products necessitating the use of emulsifiers. The effect of emulsifiers on gut health and integrity in children receiving an exclusive diet of RUTF is unknown. The PIs have recently completed a randomized, triple-blind, controlled, clinical equivalency trial in Sierra Leone comparing the alternative oat RUTF (oat-RUTF) to standard RUTF on recovery rates in children with SAM. This study demonstrated higher rates of recovery among children receiving the oat-RUTF. The investigators hypothesize that this benefit may be due to the lack of emulsifier in the oat-RUTF resulting in improved intestinal health.This research project is a double-blind, randomized, controlled clinical effectiveness trial comparing a novel RUTF containing oats and no emulsifier and standard RUTF on recovery from severe acute malnutrition (SAM) and effects on intestinal health. The trial will be conducted in up to 40 PHUs in Western Rural and Pujehun Districts where supplementary feeding programs (SFP) are not currently available.

Enrollment: 129 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• mid-upper arm circumference (MUAC) <11.5 cm

Exclusion criteria

• Children currently involved in another research trial or feeding program
• Children developmentally delayed
• have a chronic debilitating illness
• history of peanut or milk allergy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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129 participants in 2 patient groups

S-RUTF

Active Comparator group

Description:

Children will receive approximately 175 kcal/kg/d of standard ready to use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child.

Treatment:

Dietary Supplement: S-RUTF

oat-RUTF

Experimental group

Description:

Children will receive approximately 175 kcal/kg/d of oat ready-to-use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child.

Treatment:

Dietary Supplement: oat RUTF