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Ready to Use Supplementary Food in Moderate Childhood Malnutrition

M

Medecins Sans Frontieres, Netherlands

Status

Completed

Conditions

Moderate Acute Malnutrition

Treatments

Dietary Supplement: Premix CSB-oil treatment
Dietary Supplement: Ready to Use Supplementary Food

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01147198
MSFOCB1

Details and patient eligibility

About

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?).

Enrollment

570 patients

Sex

All

Ages

6 months to 5 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

570 participants in 2 patient groups

Ready to Use Supplementary Food
Active Comparator group
Description:
Ready to Use Supplementary Food treatment
Treatment:
Dietary Supplement: Ready to Use Supplementary Food
Premix
Active Comparator group
Description:
Premix Corn Soy Blend-oil treatment
Treatment:
Dietary Supplement: Premix CSB-oil treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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