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Ready to Use Supplementary Food in Moderate Childhood Malnutrition

NCT01147198 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 570

Last updated 2012-01-24

No results posted yet for this study

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?).

Conditions

  • Moderate Acute Malnutrition

Interventions

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.

DIETARY_SUPPLEMENT

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

Sponsors & Collaborators

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • Nutriset

    collaborator INDUSTRY

  • United Nations World Food Programme (WFP)

    collaborator OTHER

  • Medecins Sans Frontieres, Netherlands

    lead OTHER

Principal Investigators

  • Pascale Delchevalerie, Msc · Medecins Sans Frontieres, Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2007-08-31
Completion
2008-04-30

Countries

  • Sierra Leone

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01147198 on ClinicalTrials.gov