Ready to Use Supplementary Food in Moderate Childhood Malnutrition

Not Applicable

Completed

• Conditions: Moderate Acute Malnutrition
• Interventions: Dietary Supplement: Ready to Use Supplementary Food; Dietary Supplement: Premix CSB-oil treatment

• Registration Number: NCT01147198
• Lead Sponsor: Medecins Sans Frontieres, Netherlands

Brief Summary

Since 2001, Ready to Use Therapeutic Foods (RUTF) are widely used to treat severe malnutrition. Their efficacy and effectiveness were proven in community therapeutic care programs. Recently, the question rose if RUTF would be more effective than enriched flours to treat moderate malnutrition.

The purpose of this study is to compare the effectiveness of Ready to Use Food Supplementary-plumpy® and Premix Corn Soy Blend with oil in term of cure rate, weight gain, duration of treatment, morbidity and mortality in the treatment of moderate acute malnutrition.

Compare the longer term effect on nutritional status and morbidity (relapse?).

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-03
• Study Start: 2007-04
• Primary Completion: 2007-08
• Study Completion: 2008-04
• Study First Submitted: 2010-06-17
• Study First Submitted QC: 2010-06-17
• Study First Posted: 2010-06-22
• Last Update Submitted: 2012-01-23
• Last Update Posted: 2012-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 570

Inclusion Criteria

• all children aged 6 months to 5 years admitted to SFC outpatient care during the study period
• WHM between 70-79% (1977 NCHS/WHO standard) without edema
• approval from the caretaker

Exclusion Criteria

• presence of the following signs: bilateral edema, MUAC<110 mm , WHM< 70%(criteria for severe malnutrition), and medical complications necessitating hospitalisation
• refusal to participate from caretaker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ready to Use Supplementary Food	Ready to Use Supplementary Food	Ready to Use Supplementary Food treatment
Premix	Premix CSB-oil treatment	Premix Corn Soy Blend-oil treatment

Primary Outcome Measures

Name	Time	Method
Recovery	112 days	proportion of children who recovered, defined as WHM\> 85% for two consecutive weeks

Secondary Outcome Measures

Name	Time	Method
average weight gain	112 days	in g per kg of weight per day
Duration of treatment	112 days	average length of stay in days.
Morbidity	11 months	number of morbidity episodes during the treatment and six months thereafter

Trial Locations

Locations (1)

Health Centers run by MSF and MOH; 🇸🇱 Bo, Sierra Leone