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Different Strategies for Preventing Severe Acute Malnutrition in Niger

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01828814
First Posted: April 11, 2013
Last Update Posted: April 28, 2017
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:
United Nations World Food Programme (WFP)
Information provided by (Responsible Party):
Epicentre
  Purpose
Options for large-scale preventive distributions include fortified blended flours, ready-to-use foods and direct cash transfer either alone or in combination with family protective rations. Finding the most appropriate strategy is essential to prevent child malnutrition in countries like Niger with annual hunger gaps. Here, the investigators compare different preventive strategies on the incidence of acute malnutrition among children 6 to 23 months.

Condition
Malnutrition

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Different Strategies for Preventing Severe Acute Malnutrition in Niger: a Pragmatic Trial

Resource links provided by NLM:


Further study details as provided by Epicentre:

Primary Outcome Measures:
  • Incidence of severe acute malnutrition [ Time Frame: 15 months ]

    Severe acute malnutrition was defined as : Weight for Height Z-score (WHO Standards 2006)< -3 and/or mid-upper arm circumference (MUAC) < 115mm and/or bipedal oedema. MUAC was measured at the midpoint of a child's left arm with a plastic measuring tape with a precision of 1 mm.

    These indicators were evaluated monthly during the entire follow-up (15 months).



Secondary Outcome Measures:
  • Mortality [ Time Frame: duration of follow-up (15 months) ]
    Mortality events include all reports for which the cause for absence from surveillance visits was reported to be death by a family member.


Enrollment: 7836
Study Start Date: July 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
RUSF (500kcal/day) and cash transfer
Monthly distributions of Ready-to-use Supplementary Food (RUSF) 500kcal per day associated with cash transfer during hunger gap (5 months) then RUSF 500kcal/day for 10 months
Super Cereal Plus (SC+)
Monthly distributions of SC+ 800kcal per day during hunger gaps (5 months twice) and SC+ 400kcal per day in-between (5 months)
RUSF
Monthly distributions of Ready-to-use Supplementary Food (RUSF) 500kcal per day during hunger gaps (5 months twice) and RUSF 250kcal per day in-between (5 months)
RUSF (250kcal/day) and cash transfer
Monthly distributions of Ready-to-use Supplementary Food (RUSF) 250kcal per day associated with cash transfer during hunger gap (5 months) then RUSF 250kcal/day for 10 months
SC+ and cash transfer
Monthly distributions of Super Cereal Plus (SC+) 800 kcal per day associated with cash transfer during hunger gap (5 months)
SC+ and household ration
Monthly distributions of Super Cereal Plus (SC+) 800 kcal per day associated with food ration for household support during hunger gap (5 months)
Cash transfer
Monthly distributions of cash transfer only during hunger gap (5 months)

  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
Sampling Method:   Non-Probability Sample
Study Population
Children 6 to 24 months
Criteria

Inclusion Criteria:

  • resident in selected villages
  • height between 60 and 80 cm.

Exclusion Criteria:

  • refusal to participate
  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): NCT01828814


Locations
Niger
Villages
Madarounfa, Maradi, Niger
Sponsors and Collaborators
Epicentre
United Nations World Food Programme (WFP)
Investigators
Principal Investigator: Céline Langendorf, MPH Epicentre
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Epicentre
ClinicalTrials.gov Identifier: NCT01828814     History of Changes
Other Study ID Numbers: Epicentre
First Submitted: March 4, 2013
First Posted: April 11, 2013
Last Update Posted: April 28, 2017
Last Verified: April 2017

Keywords provided by Epicentre:
pediatrics
Ready-to-use Supplementary Food
corn soy blend
cash transfer
prevention of malnutrition
Niger

Additional relevant MeSH terms:
Malnutrition
Severe Acute Malnutrition
Nutrition Disorders