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Trial record 1 of 1 for:    NCT02085044
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Non Randomized Controlled Intervention Study Comparing Two Interventions of Nutritional Supplement on Malnutrition, Health and Mortality (NRCI-ASPE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02085044
First Posted: March 12, 2014
Last Update Posted: March 12, 2014
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:
Swiss Tropical & Public Health Institute
Information provided by (Responsible Party):
France Broillet, Médecins Sans Frontières, Switzerland
  Purpose
The hypothesis for the study is that 12 months of a Ready-To-Use Supplementary Food (RUSF) distributions have a greater impact on children's health than the standard RUSF distributions during the hunger gap period (june to september). We estimated that the 12 month RUSF will decrease the incidence of severe acute malnutrition by 33% compared to an administration only during the hunger gap period (4 month a year).

Condition Intervention Phase
Malnutrition Dietary Supplement: Ready-to-Used Supplement Food administration Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Non Randomized Controlled Intervention Study Comparing Two Interventions of Nutritional Supplement on Malnutrition, Health and Mortality in Children Aged 6 to 24 Month Hadjer-Lamis Region - Chad

Resource links provided by NLM:


Further study details as provided by France Broillet, Médecins Sans Frontières, Switzerland:

Primary Outcome Measures:
  • Incidence of acute severe malnutrition [ Time Frame: overall study time, 22 months ]

    Incidence of acute severe malnutrition will be assessed for the overall 2 years.

    Estimation if incidence will include children from their entry in the study to their exit of study (disharge as 24 months, dead of Lost of follow up )


  • Mortality rate [ Time Frame: overall study time 22 months ]
    Mortality will be assessed for the overall 2 years. Estimation will include children from their entry in the study to their exit of study (disharge as 24 months, dead of Lost of follow up )


Secondary Outcome Measures:
  • Morbidity [ Time Frame: overall study time 22 months ]
  • Gain of mid-upper-arm circumference (MUAC) gain [ Time Frame: 22 months ]
  • Weight for Height gain [ Time Frame: 22 months ]

Enrollment: 5700
Study Start Date: February 2012
Study Completion Date: December 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 12 months RUSF
Children between 6 to 24 months received ready-to-used supplementary food every months during the whole year.
Dietary Supplement: Ready-to-Used Supplement Food administration
Other Name: Plumpy 'doz
Active Comparator: 4 months RUSF
children between 6 to 24 months of one zone received a ready-to-used supplement food during the 4 months of the hunger gap period (june to september)
Dietary Supplement: Ready-to-Used Supplement Food administration
Other Name: Plumpy 'doz

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • children between 6 months and 24 months of age

Exclusion Criteria:

  • children who can 't swallow
  • children from parents who does not want to be in the study
  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): NCT02085044


Locations
Chad
Médecins Sans Frontières-OCG
Massakory, Chad
Sponsors and Collaborators
France Broillet
Swiss Tropical & Public Health Institute
Investigators
Study Chair: Annick Antierens Medecins Sans Frontieres, Netherlands
Principal Investigator: France Broillet Medecins Sans Frontieres, Netherlands
  More Information

Responsible Party: France Broillet, Chargé de recherche operationnelle, Médecins Sans Frontières, Switzerland
ClinicalTrials.gov Identifier: NCT02085044     History of Changes
Other Study ID Numbers: Médecins Sans Frontières-OCG
First Submitted: February 26, 2014
First Posted: March 12, 2014
Last Update Posted: March 12, 2014
Last Verified: October 2013

Keywords provided by France Broillet, Médecins Sans Frontières, Switzerland:
malnutrition
children's health
prevention
ready-to-use supplementary food
lipid based nutrient supplement
chad
children

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders