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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01147198
Other study ID # MSFOCB1
Secondary ID
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


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
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