- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01154595
Effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Child Malnutrition (PREAMA)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Abéché, Chad
- Action Contre La Faim Tchad
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Patrick Kolsteren, PhD MD, University Ghent
- Principal Investigator: Lieven Huybregts, PhD, University Ghent
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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.
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