Malnutrition, Child
Conditions
Brief summary
This study is to look at the types of sugar and protein composition in the treatment of moderate acute malnutrition and its effects on gut health. The study will use 4 different types of ready to use supplementary foods to see which one if any has better recovery rate along with looking into the gut health. Children will be treated using one food for up to 12 weeks. A subset of about 400 will be tested for intestinal permeability using the dual sugar test.
Interventions
DIETARY_SUPPLEMENTRUSF skimmed milk powder
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
DIETARY_SUPPLEMENTRUSF milk protein concentrate and sucrose
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
DIETARY_SUPPLEMENTRUSF soy protein and whey permeate
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
DIETARY_SUPPLEMENTRUSF soy and sucrose
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
Sponsors
Project Peanut Butter, Sierra Leone
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The RUSF food products are very similar in appearance and texture; thus, subjects and caretakers will be blinded. The investigators making the clinical assessments will not have information as to specialized food product assignment of the subject, and will remain blinded.
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No
Inclusion criteria
* MUAC \< 12.5 cm and ≥ 11.5 cm without bipedal oedema
Exclusion criteria
* If they are involved in another research trial * in another supplemental feeding program * debilitating illness * history of peanut or milk allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % lactulose excretion after 4 weeks of supplementary feeding | 4 weeks | This will only be assessed in children with higher-risk (MUAC \< 12 cm) MAM at baseline. %L measured in the urine relative to the amount ingested will be calculated. %L will be categorized as normal (\<0.2%) and abnormal (\>0.2) |
| 16S rRNA relative abundance of bacterial taxa after 4 weeks of supplementary feeding | 4 weeks | This will only be assessed in children with higher-risk (MUAC \< 12 cm) MAM at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Final mid-upper arm circumference | up to 12 weeks of treatment | Use the mid-upper are circumference at the visit when outcome was reached |
| Proportion with %L < 0.20 | 4 weeks | Percentage of children with %L excreted \< 0.20 |
| 16S rRNA beta-diversity at week 4 | 4 weeks | Looking at the 16S configuration in stool samples collected |
| 16S rRNA alpha-diversity at week 4 | 4 weeks | Several metrics of alpha diversity will be assessed, including Shannon's index |
| Rate of weight gain (g/kg/d) | up to 12 weeks of treatment | Changes in weight relative to baseline weight |
| Rate of deteriorating to severe acute malnutrition or death | up to 12 weeks of treatment | Severe acute malnutrition defined by MUAC \< 11.5 cm or development of nutritional edema |
| Sub-group analysis of %L and 16S rRNA outcomes among children not receiving breastfeeding at baseline vs. those being breastfeed at baseline | 4 weeks | Anthropometric, %L and 16s rRNA outcomes (relative abundance, alpha-diversity, beta-diversity) will be compared between study foods among those who are reported to be breastfeeding vs. those who are not |
| Sub-group analysis of anthropometric outcomes among children with MUAC < 12 cm vs. >= 12 cm at baseline | up to 12 weeks of treatment | Rate of weight change, length change, final MUAC, recovery, SAM, and death will be compared between the study foods among children with baseline MUAC \< vs. \>=12 cm. |
| Metabolomic feature abundance in the 4 dietary groups | After 4 weeks of supplementary feeding | Metabolomic feature abundance in the 4 dietary groups, as determined by untargeted metabolomics in 200 randomly selected children with MUAC \< 12.1 cm on enrollment |
| Rate of recovery from moderate acute malnutrition | up to 12 weeks of treatment | Recovery is when a participant reaches a Mid-Upper Arm Circumference of 12.5cm or better |
| Rate of length gain (mm/week) | up to 12 weeks of treatment | Changes in linear growth |
Countries
Sierra Leone
Outcome results
None listed