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A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition

NCT01593969 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-08-18

No results posted yet for this study

Summary

The investigators will perform a randomised controlled trial of the provision of food designed for rehabilitation of malnourished children that is supplemented with n-3 fatty acids compared to usual composition. The investigators want to see whether the provision of such a food normalises the deficiencies in essential fatty acids observed in severely malnourished children faster than standard composition.

Conditions

  • Severe Acute Malnutrition

Interventions

DIETARY_SUPPLEMENT

RUTF/Flax Oil

Ready to Use Therapeutic Food

DIETARY_SUPPLEMENT

RUTF/Flax Oil plus additional Fish Oil

Ready to Use Therapeutic Food

DIETARY_SUPPLEMENT

Standard RUTF

Standard formulation RUTF given according to National Guidelines

Sponsors & Collaborators

  • KEMRI-Wellcome Trust Collaborative Research Program

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • James A Berkley, FRCPCH · KEMRI-Wellcome Trust Collaborative Research Program

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-08-31
Completion
2014-06-30

Countries

  • Kenya

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 NCT01593969 on ClinicalTrials.gov