Malnutrition, Child
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTS-RUTF
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.
DIETARY_SUPPLEMENToat RUTF
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.
Sponsors
Project Peanut Butter, Sierra Leone
Ministry of Health and Sanitation, Sierra Leone
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of % of lactose excreted between enrollment and 4 weeks after enrollment | at week 4 after enrollment | %L measured in the urine relative to the amount ingested will be calculated for children in both groups. %L will be categorized as normal (\<0.2%) and abnormal (\>0.2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fecal 16S rRNA configuration after 4 weeks of feeding | after 4 weeks of feeding | Multi amplicon rRNA characterization of flash frozen stool sample |
Countries
Sierra Leone
Outcome results
None listed