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Effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Child Malnutrition (PREAMA)

Primary Purpose

Child, Malnutrition

Status
Completed
Phase
Phase 4
Locations
Chad
Study Type
Interventional
Intervention
Plumpy Doz(r) - Ready-to-Use Food
Food-for-Training
Sponsored by
Action Contre la Faim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Child focused on measuring moderate acute malnutrition, prevention, Lipid-based supplement

Eligibility Criteria

6 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • WH≥80% of median of NCHS reference without bilateral pitting oedema;
  • Age ≥ 6 months and ≤36 months;
  • Member of a household with a dependency ratio >4;
  • Not planning to leave the study zone for the coming 5 months;

Exclusion Criteria:

  • Not showing appetite;
  • Age < 6 months or age > 36 months
  • Weight-for-Height Z-score <-2 and/or the presence of bilateral pitting oedema in children 6-36 months;
  • Member of a household with a dependency ration ≤ 4;
  • Clinical complications
  • Presence of chronic illness, cardiac disease, congenital abnormalities, cancer;
  • Being allergic to one of the ingredients of the RUF.

Sites / Locations

  • Action Contre La Faim Tchad

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Food-for-Training component

Food-for-Training + RUF (Plumpy Doz(r))

Arm Description

Conditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children.

Conditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children. In addition, a blanket supplementation with 47g RUF (Plumpy Doz(r)) per day per child is provided.

Outcomes

Primary Outcome Measures

Cumulative wasting incidence, hemoglobin concentration

Secondary Outcome Measures

weight gain
time to become wasted
default rate
RUF acceptability
dietary intake

Full Information

First Posted
June 29, 2010
Last Updated
October 10, 2011
Sponsor
Action Contre la Faim
Collaborators
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT01154595
Brief Title
Effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Child Malnutrition
Acronym
PREAMA
Official Title
Effectiveness and Cost-effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Malnutrition in Children Between 6-36 Months in Urban Chad
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Action Contre la Faim
Collaborators
University Ghent

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The overall objective of this project is to assess the effectiveness and cost-effectiveness of RUF (ready-to-Use Food, Plumpy Doz(r)) to prevent moderate acute malnutrition in children aged 6-36 months if embedded in a program of conditional household food assistance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child, Malnutrition
Keywords
moderate acute malnutrition, prevention, Lipid-based supplement

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Food-for-Training component
Arm Type
Active Comparator
Arm Description
Conditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children.
Arm Title
Food-for-Training + RUF (Plumpy Doz(r))
Arm Type
Experimental
Arm Description
Conditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children. In addition, a blanket supplementation with 47g RUF (Plumpy Doz(r)) per day per child is provided.
Intervention Type
Dietary Supplement
Intervention Name(s)
Plumpy Doz(r) - Ready-to-Use Food
Intervention Description
47g Plumpy Doz(r) per day per child
Intervention Type
Behavioral
Intervention Name(s)
Food-for-Training
Intervention Description
Conditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children.
Primary Outcome Measure Information:
Title
Cumulative wasting incidence, hemoglobin concentration
Time Frame
monthly
Secondary Outcome Measure Information:
Title
weight gain
Time Frame
monthly
Title
time to become wasted
Time Frame
monthly
Title
default rate
Time Frame
monthly
Title
RUF acceptability
Time Frame
monthly
Title
dietary intake
Time Frame
monthly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: WH≥80% of median of NCHS reference without bilateral pitting oedema; Age ≥ 6 months and ≤36 months; Member of a household with a dependency ratio >4; Not planning to leave the study zone for the coming 5 months; Exclusion Criteria: Not showing appetite; Age < 6 months or age > 36 months Weight-for-Height Z-score <-2 and/or the presence of bilateral pitting oedema in children 6-36 months; Member of a household with a dependency ration ≤ 4; Clinical complications Presence of chronic illness, cardiac disease, congenital abnormalities, cancer; Being allergic to one of the ingredients of the RUF.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Kolsteren, PhD MD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lieven Huybregts, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Action Contre La Faim Tchad
City
Abéché
Country
Chad

12. IPD Sharing Statement

Citations:
PubMed Identifier
23028263
Citation
Huybregts L, Houngbe F, Salpeteur C, Brown R, Roberfroid D, Ait-Aissa M, Kolsteren P. The effect of adding ready-to-use supplementary food to a general food distribution on child nutritional status and morbidity: a cluster-randomized controlled trial. PLoS Med. 2012;9(9):e1001313. doi: 10.1371/journal.pmed.1001313. Epub 2012 Sep 18.
Results Reference
derived

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Effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Child Malnutrition

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