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
  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:


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
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, see Learn About Clinical Studies.

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
Nutrition Disorders

ClinicalTrials.gov processed this record on September 18, 2014