- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01828814
Different Strategies for Preventing Severe Acute Malnutrition in Niger
April 27, 2017 updated by: Epicentre
Different Strategies for Preventing Severe Acute Malnutrition in Niger: a Pragmatic Trial
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
7836
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maradi
-
Madarounfa, Maradi, Niger
- Villages
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 2 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children 6 to 24 months
Description
Inclusion Criteria:
- resident in selected villages
- height between 60 and 80 cm.
Exclusion Criteria:
- refusal to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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). |
15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
duration of follow-up (15 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Céline Langendorf, MPH, Epicentre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sayyad-Neerkorn J, Langendorf C, Roederer T, Doyon S, Mamaty AA, Woi-Messe L, Manzo ML, Harouna S, de Pee S, Grais RF. Preventive Effects of Long-Term Supplementation with 2 Nutritious Food Supplements in Young Children in Niger. J Nutr. 2015 Nov;145(11):2596-603. doi: 10.3945/jn.115.213157. Epub 2015 Sep 30.
- Langendorf C, Roederer T, de Pee S, Brown D, Doyon S, Mamaty AA, Toure LW, Manzo ML, Grais RF. Preventing acute malnutrition among young children in crises: a prospective intervention study in Niger. PLoS Med. 2014 Sep 2;11(9):e1001714. doi: 10.1371/journal.pmed.1001714. eCollection 2014 Sep.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
March 4, 2013
First Submitted That Met QC Criteria
April 8, 2013
First Posted (Estimate)
April 11, 2013
Study Record Updates
Last Update Posted (Actual)
April 28, 2017
Last Update Submitted That Met QC Criteria
April 27, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Epicentre
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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