Ready to Use Supplementary Food in Moderate Childhood Malnutrition

Moderate Acute Malnutrition Clinical Trial

Official title:

Effectiveness of a Ready-to-Use-Supplementary-Food for the Treatment of Moderate Childhood Malnutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147198
• Other study ID #: MSFOCB1
• Status: Completed
• Phase: N/A
• First received: June 17, 2010
• Last updated: January 23, 2012
• Start date: April 2007
• Est. completion date: April 2008

Study information

• Verified date: March 2007
• Source: Medecins Sans Frontieres
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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?).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 570
• Est. completion date: April 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition
• Moderate Acute Malnutrition

Intervention

Dietary Supplement:
• Ready to Use Supplementary Food
Children received two Supplementary-plumpy® packages per day (184g) providing 1000 Kcal, 26g (10.4%) protein, 68g (61.2%) fat, and 100% of micronutrient requirements based on the Daily Recommended Nutrient Intake.
• Premix CSB-oil treatment
Children received 2 kg of premix per week (226g CSB, 37g oil, and 23g sugar / day) providing 1277 Kcal, 40.7g protein (12.7%), 50.6g (35.7%) fat, and 100% of micronutrient according to the DRNI guidelines

Locations

Country	Name	City	State
Sierra Leone	Health Centers run by MSF and MOH	Bo

Sponsors (4)

Lead Sponsor	Collaborator
Medecins Sans Frontieres	London School of Hygiene and Tropical Medicine, Nutriset, United Nations World Food Programme (WFP)

Country where clinical trial is conducted

Sierra Leone, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery	proportion of children who recovered, defined as WHM> 85% for two consecutive weeks	112 days	No
Secondary	average weight gain	in g per kg of weight per day	112 days	No
Secondary	Duration of treatment	average length of stay in days.	112 days	No
Secondary	Morbidity	number of morbidity episodes during the treatment and six months thereafter	11 months	No