Ready to Use Supplementary Food in Moderate Childhood Malnutrition

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01147198

Enrollment

570

Registered

2010-06-22

Start date

2007-04-30

Completion date

2008-04-30

Last updated

2012-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate Acute Malnutrition

Keywords

Moderate, Wasting, Malnutrition, Ready to Use Food, Fortified Blended Flour

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?).

Interventions

DIETARY_SUPPLEMENTReady 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_SUPPLEMENTPremix 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 5 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Sierra Leone

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026