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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

June 29, 2010
October 10, 2011
June 2010
February 2011   (final data collection date for primary outcome measure)
Cumulative wasting incidence, hemoglobin concentration [ Time Frame: monthly ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01154595 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Child Malnutrition
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Child
  • Malnutrition
  • 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.
  • 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.
    Intervention: Behavioral: Food-for-Training
  • 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.

    Interventions:
    • Dietary Supplement: Plumpy Doz(r) - Ready-to-Use Food
    • Behavioral: Food-for-Training
Huybregts L, Houngbé F, Salpéteur 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 Sep;9(9):e1001313. doi: 10.1371/journal.pmed.1001313. Epub 2012 Sep 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2000
February 2011
February 2011   (final data collection date for primary outcome measure)

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.
Both
6 Months to 36 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Chad
 
NCT01154595
UGENT0410
Yes
Lieven Huybregts, University Ghent
Action Contre la Faim
University Ghent
Principal Investigator: Patrick Kolsteren, PhD MD University Ghent
Principal Investigator: Lieven Huybregts, PhD University Ghent
Action Contre la Faim
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP