Clinical trial NCT04216043: 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
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition, Child
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Project Peanut Butter, Sierra Leone
First posted: 2020-01-02
Enrollment: 1102
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: % lactulose excretion after 4 weeks of supplementary feeding
timeFrame: 4 weeks
measure: 16S rRNA relative abundance of bacterial taxa after 4 weeks of supplementary feeding
timeFrame: 4 weeks
Secondary outcomes:
measure: Rate of weight gain (g/kg/d)
timeFrame: up to 12 weeks of treatment
measure: Rate of length gain (mm/week)
timeFrame: up to 12 weeks of treatment
measure: Final mid-upper arm circumference
timeFrame: up to 12 weeks of treatment
measure: Proportion with %L < 0.20
timeFrame: 4 weeks
measure: 16S rRNA beta-diversity at week 4
timeFrame: 4 weeks
measure: 16S rRNA alpha-diversity at week 4
timeFrame: 4 weeks
measure: Rate of recovery from moderate acute malnutrition
timeFrame: up to 12 weeks of treatment
measure: Rate of deteriorating to severe acute malnutrition or death
timeFrame: up to 12 weeks of treatment
measure: Sub-group analysis of %L and 16S rRNA outcomes among children not receiving breastfeeding at baseline vs. those being breastfeed at baseline
timeFrame: 4 weeks
measure: Sub-group analysis of anthropometric outcomes among children with MUAC < 12 cm vs. >= 12 cm at baseline
timeFrame: up to 12 weeks of treatment
measure: Metabolomic feature abundance in the 4 dietary groups
timeFrame: After 4 weeks of supplementary feeding
Other outcomes:
Locations:
city: Freetown
country: Sierra Leone
facility: Project Peanut Butter Factory
Study officials:
affiliation: Washington University School of Medicine
name: Mark Manary, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Shankar AH. Nutritional modulation of malaria morbidity and mortality. J Infect Dis. 2000 Sep;182 Suppl 1:S37-53. doi: 10.1086/315906.
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.
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.