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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04216043
Other study ID # 201912091
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 16, 2020
Est. completion date March 7, 2022

Study information

Verified date January 2024
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1102
Est. completion date March 7, 2022
Est. primary completion date March 7, 2022
Accepts healthy volunteers No
Gender All
Age group 6 Months to 59 Months
Eligibility 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

Study Design


Intervention

Dietary Supplement:
RUSF skimmed milk powder
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
RUSF 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
RUSF 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
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

Locations

Country Name City State
Sierra Leone Project Peanut Butter Factory Freetown

Sponsors (2)

Lead Sponsor Collaborator
Washington University School of Medicine Project Peanut Butter, Sierra Leone

Country where clinical trial is conducted

Sierra Leone, 

References & Publications (5)

Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available. — View Citation

Caulfield LE, de Onis M, Blossner M, Black RE. Undernutrition as an underlying cause of child deaths associated with diarrhea, pneumonia, malaria, and measles. Am J Clin Nutr. 2004 Jul;80(1):193-8. doi: 10.1093/ajcn/80.1.193. — View Citation

Matilsky DK, Maleta K, Castleman T, Manary MJ. Supplementary feeding with fortified spreads results in higher recovery rates than with a corn/soy blend in moderately wasted children. J Nutr. 2009 Apr;139(4):773-8. doi: 10.3945/jn.108.104018. Epub 2009 Feb 18. — View Citation

Nackers F, Broillet F, Oumarou D, Djibo A, Gaboulaud V, Guerin PJ, Rusch B, Grais RF, Captier V. Effectiveness of ready-to-use therapeutic food compared to a corn/soy-blend-based pre-mix for the treatment of childhood moderate acute malnutrition in Niger. J Trop Pediatr. 2010 Dec;56(6):407-13. doi: 10.1093/tropej/fmq019. Epub 2010 Mar 23. — View Citation

Shankar AH. Nutritional modulation of malaria morbidity and mortality. J Infect Dis. 2000 Sep;182 Suppl 1:S37-53. doi: 10.1086/315906. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary % 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)
4 weeks
Primary 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 4 weeks
Secondary Rate of weight gain (g/kg/d) Changes in weight relative to baseline weight up to 12 weeks of treatment
Secondary Rate of length gain (mm/week) Changes in linear growth up to 12 weeks of treatment
Secondary Final mid-upper arm circumference Use the mid-upper are circumference at the visit when outcome was reached up to 12 weeks of treatment
Secondary Proportion with %L < 0.20 Percentage of children with %L excreted < 0.20 4 weeks
Secondary 16S rRNA beta-diversity at week 4 Looking at the 16S configuration in stool samples collected 4 weeks
Secondary 16S rRNA alpha-diversity at week 4 Several metrics of alpha diversity will be assessed, including Shannon's index 4 weeks
Secondary Rate of recovery from moderate acute malnutrition Recovery is when a participant reaches a Mid-Upper Arm Circumference of 12.5cm or better up to 12 weeks of treatment
Secondary Rate of deteriorating to severe acute malnutrition or death Severe acute malnutrition defined by MUAC < 11.5 cm or development of nutritional edema up to 12 weeks of treatment
Secondary 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 4 weeks
Secondary 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. up to 12 weeks of treatment
Secondary 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 After 4 weeks of supplementary feeding
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