Trials / Completed
CompletedNCT02994212
Reduced Visit Frequency in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety
Reduced Frequency of Visits in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 115 (actual)
- Sponsor
- Epicentre · Academic / Other
- Sex
- All
- Age
- 6 Months – 59 Months
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Monthly distribution of RUTF | 115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF. |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2014-11-01
- Completion
- 2014-11-01
- First posted
- 2016-12-15
- Last updated
- 2019-12-04
Source: ClinicalTrials.gov record NCT02994212. Inclusion in this directory is not an endorsement.