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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02994212
Other study ID # 821414-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2014
Est. completion date November 2014

Study information

Verified date December 2019
Source Epicentre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 115
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender All
Age group 6 Months to 59 Months
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Monthly distribution of RUTF
115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Epicentre Médecins Sans Frontières, France

Outcome

Type Measure Description Time frame Safety issue
Primary weight gain grams/kilograms/day gained 4 weeks
Primary mid-upper arm circumference gain (mm/day) millimeters gained per day 4 weeks
Primary weight loss > 5% 4 weeks
Primary development of edema 4 weeks
Secondary correct utilization of RUTF > 2 sachets deviance between available and expected RUTF stocks at unannounced household visits 4 weeks
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