We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01154595
First Posted: July 1, 2010
Last Update Posted: October 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Ghent
Information provided by (Responsible Party):
Lieven Huybregts, University Ghent
  Purpose
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.

Condition Intervention Phase
Child Malnutrition Dietary Supplement: Plumpy Doz(r) - Ready-to-Use Food Behavioral: Food-for-Training Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Lieven Huybregts, University Ghent:

Primary Outcome Measures:
  • Cumulative wasting incidence, hemoglobin concentration [ Time Frame: monthly ]

Secondary Outcome Measures:
  • weight gain [ Time Frame: monthly ]
  • time to become wasted [ Time Frame: monthly ]
  • default rate [ Time Frame: monthly ]
  • RUF acceptability [ Time Frame: monthly ]
  • dietary intake [ Time Frame: monthly ]

Estimated Enrollment: 2000
Study Start Date: June 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Food-for-Training
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.

Dietary Supplement: Plumpy Doz(r) - Ready-to-Use Food
47g Plumpy Doz(r) per day per child
Behavioral: Food-for-Training
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154595


Locations
Chad
Action Contre La Faim Tchad
Abéché, Chad
Sponsors and Collaborators
Action Contre la Faim
University Ghent
Investigators
Principal Investigator: Patrick Kolsteren, PhD MD University Ghent
Principal Investigator: Lieven Huybregts, PhD University Ghent
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lieven Huybregts, Principal Investigator, University Ghent
ClinicalTrials.gov Identifier: NCT01154595     History of Changes
Other Study ID Numbers: UGENT0410
First Submitted: June 29, 2010
First Posted: July 1, 2010
Last Update Posted: October 12, 2011
Last Verified: October 2011

Keywords provided by Lieven Huybregts, University Ghent:
moderate acute malnutrition, prevention, Lipid-based supplement

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders