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OpenTrials
Completed

NCT Number: NCT01147198

Ready to Use Supplementary Food in Moderate Childhood Malnutrition

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?).

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Key information

Conditions

Moderate Acute Malnutrition Body Weight Body Weight Changes Cachexia Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Malnutrition Neoplasms Neoplasms by Histologic Type Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Weight Loss

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Centers run by MSF and MOH

Bo, Sierra Leone

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ready to Use Supplementary Food

Dietary Supplement

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.

Other names: Supplementary-plumpy®

Premix CSB-oil treatment

Dietary Supplement

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

Other names: Corn Soy Blend, Fortified Blended Flours

Primary outcomes

  1. Recovery

    Time frame: 112 days

    proportion of children who recovered, defined as WHM> 85% for two consecutive weeks

Secondary outcomes

  1. average weight gain

    Time frame: 112 days

    in g per kg of weight per day

  2. Duration of treatment

    Time frame: 112 days

    average length of stay in days.

  3. Morbidity

    Time frame: 11 months

    number of morbidity episodes during the treatment and six months thereafter

Sponsors and collaborators

Lead sponsor

Medecins Sans Frontieres, Netherlands

Other

Collaborators

  • London School of Hygiene and Tropical Medicine
  • Nutriset
  • United Nations World Food Programme (WFP)

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Jun 22, 2010
Registry last updated
Jan 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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