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OpenTrials
Completed

NCT Number: NCT02994212

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

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.

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Key information

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Monthly distribution of RUTF

Dietary Supplement

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

Primary outcomes

  1. weight gain

    Time frame: 4 weeks

    grams/kilograms/day gained

  2. mid-upper arm circumference gain (mm/day)

    Time frame: 4 weeks

    millimeters gained per day

  3. weight loss > 5%

    Time frame: 4 weeks

  4. development of edema

    Time frame: 4 weeks

Secondary outcomes

  1. correct utilization of RUTF

    Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

Epicentre

Other

Collaborators

  • Médecins Sans Frontières, France

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 15, 2016
Registry last updated
Dec 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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