An interventional study of RUSF skimmed milk powder and RUSF milk protein concentrate and sucrose in Malnutrition, Child, sponsored by Washington University School of Medicine. Completed at 1 site in Sierra Leone. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
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.
167 studies on the registry are indexed under Child Nutrition Disorders; 36 are open to participants now.
This study's enrollment of 1,102 is above the median of 402 across 132 interventional studies indexed under Child Nutrition Disorders.
Browse Child Nutrition Disorders studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
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Exclusion Criteria:
RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions.
Dietary Supplement: RUSF skimmed milk powder
RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions.
Dietary Supplement: RUSF milk protein concentrate and sucrose
RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions.
Dietary Supplement: RUSF soy protein and whey permeate
RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions.
Dietary Supplement: RUSF soy and sucrose
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
% lactulose excretion after 4 weeks of supplementary feeding
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)
Time frame: 4 weeks
16S rRNA relative abundance of bacterial taxa after 4 weeks of supplementary feeding
This will only be assessed in children with higher-risk (MUAC \< 12 cm) MAM at baseline
Time frame: 4 weeks
Rate of weight gain (g/kg/d)
Changes in weight relative to baseline weight
Time frame: up to 12 weeks of treatment
Rate of length gain (mm/week)
Changes in linear growth
Time frame: up to 12 weeks of treatment
Final mid-upper arm circumference
Use the mid-upper are circumference at the visit when outcome was reached
Time frame: up to 12 weeks of treatment
Proportion with %L < 0.20
Percentage of children with %L excreted \< 0.20
Time frame: 4 weeks
16S rRNA beta-diversity at week 4
Looking at the 16S configuration in stool samples collected
Time frame: 4 weeks
16S rRNA alpha-diversity at week 4
Several metrics of alpha diversity will be assessed, including Shannon's index
Time frame: 4 weeks
Rate of recovery from moderate acute malnutrition
Recovery is when a participant reaches a Mid-Upper Arm Circumference of 12.5cm or better
Time frame: up to 12 weeks of treatment
Rate of deteriorating to severe acute malnutrition or death
Severe acute malnutrition defined by MUAC \< 11.5 cm or development of nutritional edema
Time frame: up to 12 weeks of treatment
Sub-group analysis of %L and 16S rRNA outcomes among children not receiving breastfeeding at baseline vs. those being breastfeed at baseline
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
Time frame: 4 weeks
Sub-group analysis of anthropometric outcomes among children with MUAC < 12 cm vs. >= 12 cm at baseline
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.
Time frame: up to 12 weeks of treatment
Metabolomic feature abundance in the 4 dietary groups
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
Time frame: After 4 weeks of supplementary feeding
Ran from Sep 2020 to primary completion in Mar 2022, 17 months.
Of 81 non-industry interventional studies with no phase under Child Nutrition Disorders, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 36. This study's 17 months is below that.
Counting every sponsor, half of 84 studies reached it within 19 months; a quarter within 11 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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