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Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition

NCT02053857 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2014-09-29

No results posted yet for this study

Summary

To test whether a ready-to-use therapeutic food (RUTF) enriched with polyunsaturated fatty acids (RUTF-P) is as effective for the treatment of severe acute malnutrition (SAM) as standard RUTF.

Conditions

  • Kwashiorkor
  • Marasmus

Interventions

DIETARY_SUPPLEMENT

RUTF

DIETARY_SUPPLEMENT

RUTF-P

DRUG

Amoxicillin

Sponsors & Collaborators

  • University of Malawi

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Mark J Manary, MD · Washington University School of Medicine

  • Kenneth Maleta, MBBS PhD · University of Malawi

  • Chrissie Thakwalakwa · University of Malawi

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
2014-02-28
Primary Completion
2014-07-31
Completion
2014-07-31

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 NCT02053857 on ClinicalTrials.gov