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High-protein Quantity and Quality RUTF in Improving Linear Growth Among Children With Severe Wasting

NCT05737472 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2024-04-30

No results posted yet for this study

Summary

This is a proof-of-concept trial that aims to compare the efficacy of an 8-week treatment with higher-protein-Ready-to-Use Therapeutic Foods (RUTF) with standard RUTF in improving levels of markers of growths, height, nutritional recovery, and lean mass deposition among children with severe wasting. The study will also assess the safety and acceptability of the high-protein RUTF in comparison to the standard RUTF. The study will be conducted at four outpatient therapeutic programs in the Blantyre district of Malawi.

Conditions

  • Severe Wasting
  • Severe Acute Malnutrition

Interventions

DIETARY_SUPPLEMENT

High-protein RUTF

The high-protein RUTF is isocaloric to the standard RUTF. To have a higher protein quantity and quality, the recipe has greater proportions of milk powder plus whey protein and vegetable oil. A total of 15% of energy is from protein. The protein quality score, digestible indispensable amino acid score (DIAAS )of the high protein, RUTF is 1.18 which is equivalent to a Protein Digestibility Corrected Amino Acid Score (PDCAAS) of 1.19

DIETARY_SUPPLEMENT

Standard RUTF

The standard RUTF was manufactured according to WHO recommendations, with at least 50% of protein-sourced dairy, mainly skim milk. A total of 10% of energy is from protein. The protein quality score, digestible indispensable amino acid score (DIAAS) of the standard RUTF is 0.76, which is equivalent to a Protein Digestibility Corrected Amino Acid Score (PDCAAS) of 0.86.

Sponsors & Collaborators

  • Ministry of Health, Malawi

    collaborator OTHER_GOV

  • Schlumberger Foundation

    collaborator UNKNOWN

  • Nutriset

    collaborator INDUSTRY

  • Friends of Sick Children, Malawi

    collaborator UNKNOWN

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Isabel Potani, PhD(c) · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-11-14
Primary Completion
2023-07-26
Completion
2023-08-23

Countries

  • Malawi

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 NCT05737472 on ClinicalTrials.gov