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

This study has been completed.
Sponsor:
Collaborator:
University Ghent
Information provided by (Responsible Party):
Lieven Huybregts, University Ghent
ClinicalTrials.gov Identifier:
NCT01154595
First received: June 29, 2010
Last updated: October 10, 2011
Last verified: October 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

U.S. FDA Resources

Further study details as provided by Action Contre la Faim:

Primary Outcome Measures:
  • Cumulative wasting incidence, hemoglobin concentration [ Time Frame: monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • weight gain [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • time to become wasted [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • default rate [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • RUF acceptability [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • dietary intake [ Time Frame: monthly ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Action Contre la Faim

Additional 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
Study First Received: June 29, 2010
Last Updated: October 10, 2011
Health Authority: Chad: Ministry of Health

Keywords provided by Action Contre la Faim:
moderate acute malnutrition, prevention, Lipid-based supplement

Additional relevant MeSH terms:
Malnutrition
Child Nutrition Disorders
Nutrition Disorders

ClinicalTrials.gov processed this record on May 16, 2013