Ready to Use Supplementary Food in Moderate Childhood Mal... | NCT01147198

Studies
Ready to Use Supplementary Food in Moderate Childhood Malnutrition

NCT01147198

Sponsor

Medecins Sans Frontieres, Netherlands

Status

Completed

Last Update Posted

Jan 24, 2012Estimated

Enrollment

570Actual

Phase

Not Applicable

Conditions

Moderate Acute Malnutrition

Interventions

Ready to Use Supplementary Food
Premix CSB-oil treatment

Countries

Sierra Leone

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Aug 2007Actual

Completion Date

Apr 2008Actual

First Submitted Date

Jun 17, 2010

First Submission Date that Met QC Criteria

Jun 17, 2010

First Posted Date

Jun 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2012

Last Update Posted Date

Jan 24, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Medecins Sans Frontieres, NetherlandsOTHER

Collaborators

Name	Class
London School of Hygiene and Tropical Medicine	OTHER
Nutriset	INDUSTRY
United Nations World Food Programme (WFP)	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

570Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ready to Use Supplementary Food	Active Comparator	Ready to Use Supplementary Food treatment	Dietary Supplement: Ready to Use Supplementary Food
Premix	Active Comparator	Premix Corn Soy Blend-oil treatment	Dietary Supplement: Premix CSB-oil treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
average weight gain	in g per kg of weight per day	112 days
Duration of treatment	average length of stay in days.	112 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pascale Delchevalerie, Msc	Medecins Sans Frontieres, Netherlands	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Health Centers run by MSF and MOH		Bo	Bo		Sierra Leone

Condition Browse Module

MeSH Terms

ID	Term
D008224	Lymphoma, Follicular
D002100	Cachexia
D044342	Malnutrition

Ancestor Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided