Effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Child Malnutrition (PREAMA)
October 10, 2011 updated by: Lieven Huybregts, Action Contre la Faim
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
2000
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Abéché, Chad
- Action Contre La Faim Tchad
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 8 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Food-for-Training component
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.
|
|
Experimental: Food-for-Training + RUF (Plumpy Doz(r))
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. |
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.
47g Plumpy Doz(r) per day per child
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cumulative wasting incidence, hemoglobin concentration
Time Frame: monthly
|
monthly
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
weight gain
Time Frame: monthly
|
monthly
|
|
time to become wasted
Time Frame: monthly
|
monthly
|
|
default rate
Time Frame: monthly
|
monthly
|
|
RUF acceptability
Time Frame: monthly
|
monthly
|
|
dietary intake
Time Frame: monthly
|
monthly
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Patrick Kolsteren, PhD MD, University Ghent
- Principal Investigator: Lieven Huybregts, PhD, University Ghent
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
June 29, 2010
First Submitted That Met QC Criteria
June 30, 2010
First Posted (Estimate)
July 1, 2010
Study Record Updates
Last Update Posted (Estimate)
October 12, 2011
Last Update Submitted That Met QC Criteria
October 10, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UGENT0410
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.