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Milk Matters in Malnutrition, is it the Lactose or Dairy Protein?

NCT04216043 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1102

Last updated 2024-01-05

No results posted yet for this study

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.

Conditions

  • Malnutrition, Child

Interventions

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

DIETARY_SUPPLEMENT

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

DIETARY_SUPPLEMENT

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

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

Sponsors & Collaborators

  • Project Peanut Butter, Sierra Leone

    collaborator UNKNOWN

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Mark Manary, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2022-03-07
Completion
2022-03-07

Countries

  • Sierra Leone

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04216043 on ClinicalTrials.gov