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Reduced Visit Frequency in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety

NCT02994212 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2019-12-04

No results posted yet for this study

Summary

Community-based management of severe acute malnutrition (SAM) has been shown to be safe and cost-effective, but program coverage remains low. New treatment models that maintain high levels of clinical effectiveness but allow for increased coverage are still needed. A reduced schedule of follow-up, in which children receive clinical follow-up and therapeutic foods on a monthly rather than weekly or biweekly basis, may be one alternative. This study aims to describe the safety and feasibility of a monthly distribution of ready-to-use therapeutic food in the treatment of uncomplicated SAM, in terms of clinical response to treatment and household ready-to-use therapeutic food (RUTF) utilization. This is a non-randomized pilot intervention study in which 115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF. Anthropometric measurements were taken on a weekly basis for 4 weeks to monitor treatment response defined as weight gain, (mid-upper arm circumference) MUAC gain, weight loss \> 5%, and the development of edema. Unannounced household spot checks were conducted over 4 weeks to assess household utilization of RUTF and storage practices.

Conditions

  • Severe Acute Malnutrition

Interventions

DIETARY_SUPPLEMENT

Monthly distribution of RUTF

115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF.

Sponsors & Collaborators

  • Médecins Sans Frontières, France

    collaborator OTHER

  • Epicentre

    lead OTHER

Principal Investigators

  • Sheila Isanaka, ScD · Epicentre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2014-11-30
Completion
2014-11-30

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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 NCT02994212 on ClinicalTrials.gov