search
Back to results

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

Primary Purpose

Severe Acute Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Monthly distribution of RUTF
Sponsored by
Epicentre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Acute Malnutrition

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a) being eligible for new admission to treatment of uncomplicated SAM
  • b) being resident within 15 km of the study health center

Exclusion Criteria:

  • previously default from previous SAM treatment (e.g. missed 2 consecutive weekly visits)
  • considered a relapse case (e.g. re-admitted within three months of previous discharge)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention group

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    weight gain
    grams/kilograms/day gained
    mid-upper arm circumference gain (mm/day)
    millimeters gained per day
    weight loss > 5%
    development of edema

    Secondary Outcome Measures

    correct utilization of RUTF
    > 2 sachets deviance between available and expected RUTF stocks at unannounced household visits

    Full Information

    First Posted
    December 13, 2016
    Last Updated
    December 3, 2019
    Sponsor
    Epicentre
    Collaborators
    Médecins Sans Frontières, France
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02994212
    Brief Title
    Reduced Visit Frequency in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety
    Official Title
    Reduced Frequency of Visits in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Epicentre
    Collaborators
    Médecins Sans Frontières, France

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Severe Acute Malnutrition

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    115 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Monthly distribution of RUTF
    Intervention Description
    115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF.
    Primary Outcome Measure Information:
    Title
    weight gain
    Description
    grams/kilograms/day gained
    Time Frame
    4 weeks
    Title
    mid-upper arm circumference gain (mm/day)
    Description
    millimeters gained per day
    Time Frame
    4 weeks
    Title
    weight loss > 5%
    Time Frame
    4 weeks
    Title
    development of edema
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    correct utilization of RUTF
    Description
    > 2 sachets deviance between available and expected RUTF stocks at unannounced household visits
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    59 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: a) being eligible for new admission to treatment of uncomplicated SAM b) being resident within 15 km of the study health center Exclusion Criteria: previously default from previous SAM treatment (e.g. missed 2 consecutive weekly visits) considered a relapse case (e.g. re-admitted within three months of previous discharge)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sheila Isanaka, ScD
    Organizational Affiliation
    Epicentre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28404577
    Citation
    Isanaka S, Kodish SR, Berthe F, Alley I, Nackers F, Hanson KE, Grais RF. Outpatient treatment of severe acute malnutrition: response to treatment with a reduced schedule of therapeutic food distribution. Am J Clin Nutr. 2017 May;105(5):1191-1197. doi: 10.3945/ajcn.116.148064. Epub 2017 Apr 12.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs