Back to resultsMilk Matters in Malnutrition, is it the Lactose or Dairy Protein?
Primary Purpose
Malnutrition, Child
Status
Completed
Phase
Not Applicable
Locations
Sierra Leone
Study Type
Interventional
Intervention
RUSF skimmed milk powder
RUSF milk protein concentrate and sucrose
RUSF soy protein and whey permeate
RUSF soy and sucrose
Sponsored by
About this trial
This is an interventional treatment trial for Malnutrition, Child
Eligibility Criteria
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
Sites / Locations
- Project Peanut Butter Factory
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
RUSF skimmed milk powder
RUSF milk protein concentrate and sucrose
RUSF soy protein and whey permeate
RUSF soy and sucrose
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
% 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)
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
Secondary Outcome Measures
Rate of weight gain (g/kg/d)
Changes in weight relative to baseline weight
Rate of length gain (mm/week)
Changes in linear growth
Final mid-upper arm circumference
Use the mid-upper are circumference at the visit when outcome was reached
Proportion with %L < 0.20
Percentage of children with %L excreted < 0.20
16S rRNA beta-diversity at week 4
Looking at the 16S configuration in stool samples collected
16S rRNA alpha-diversity at week 4
Several metrics of alpha diversity will be assessed, including Shannon's index
Rate of recovery from moderate acute malnutrition
Recovery is when a participant reaches a Mid-Upper Arm Circumference of 12.5cm or better
Rate of deteriorating to severe acute malnutrition or death
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
o 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
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.
Full Information
NCT ID
NCT04216043
First Posted
December 23, 2019
Last Updated
May 23, 2022
Sponsor
Washington University School of Medicine
Collaborators
Project Peanut Butter, Sierra Leone
1. Study Identification
Unique Protocol Identification Number
NCT04216043
Brief Title
Milk Matters in Malnutrition, is it the Lactose or Dairy Protein?
Official Title
Milk Matters in Malnutrition, is it the Lactose or Dairy Protein?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
March 7, 2022 (Actual)
Study Completion Date
March 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Project Peanut Butter, Sierra Leone
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Child
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
1102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RUSF skimmed milk powder
Arm Type
Experimental
Arm Description
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.
Arm Title
RUSF milk protein concentrate and sucrose
Arm Type
Experimental
Arm Description
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.
Arm Title
RUSF soy protein and whey permeate
Arm Type
Experimental
Arm Description
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.
Arm Title
RUSF soy and sucrose
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
RUSF skimmed milk powder
Intervention Description
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
Intervention Type
Dietary Supplement
Intervention Name(s)
RUSF milk protein concentrate and sucrose
Intervention Description
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
Intervention Type
Dietary Supplement
Intervention Name(s)
RUSF soy protein and whey permeate
Intervention Description
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
Intervention Type
Dietary Supplement
Intervention Name(s)
RUSF soy and sucrose
Intervention Description
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
Primary Outcome Measure Information:
Title
% lactulose excretion after 4 weeks of supplementary feeding
Description
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
Title
16S rRNA relative abundance of bacterial taxa after 4 weeks of supplementary feeding
Description
This will only be assessed in children with higher-risk (MUAC < 12 cm) MAM at baseline
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Rate of weight gain (g/kg/d)
Description
Changes in weight relative to baseline weight
Time Frame
up to 12 weeks of treatment
Title
Rate of length gain (mm/week)
Description
Changes in linear growth
Time Frame
up to 12 weeks of treatment
Title
Final mid-upper arm circumference
Description
Use the mid-upper are circumference at the visit when outcome was reached
Time Frame
up to 12 weeks of treatment
Title
Proportion with %L < 0.20
Description
Percentage of children with %L excreted < 0.20
Time Frame
4 weeks
Title
16S rRNA beta-diversity at week 4
Description
Looking at the 16S configuration in stool samples collected
Time Frame
4 weeks
Title
16S rRNA alpha-diversity at week 4
Description
Several metrics of alpha diversity will be assessed, including Shannon's index
Time Frame
4 weeks
Title
Rate of recovery from moderate acute malnutrition
Description
Recovery is when a participant reaches a Mid-Upper Arm Circumference of 12.5cm or better
Time Frame
up to 12 weeks of treatment
Title
Rate of deteriorating to severe acute malnutrition or death
Description
Severe acute malnutrition defined by MUAC < 11.5 cm or development of nutritional edema
Time Frame
up to 12 weeks of treatment
Title
Sub-group analysis of %L and 16S rRNA outcomes among children not receiving breastfeeding at baseline vs. those being breastfeed at baseline
Description
o 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
Title
Sub-group analysis of anthropometric outcomes among children with MUAC < 12 cm vs. >= 12 cm at baseline
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Manary, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Project Peanut Butter Factory
City
Freetown
Country
Sierra Leone
12. IPD Sharing Statement
Citations:
PubMed Identifier
18207566
Citation
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.
Results Reference
background
PubMed Identifier
15213048
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.
Results Reference
background
PubMed Identifier
10944483
Citation
Shankar AH. Nutritional modulation of malaria morbidity and mortality. J Infect Dis. 2000 Sep;182 Suppl 1:S37-53. doi: 10.1086/315906.
Results Reference
background
PubMed Identifier
19225128
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.
Results Reference
background
PubMed Identifier
20332221
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.
Results Reference
background
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Milk Matters in Malnutrition, is it the Lactose or Dairy Protein?
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