MalnutritionNCT01828814
Different Strategies for Preventing Severe Acute Malnutrition in Niger
An observational study of Malnutrition, run by Epicentre at 1 site in Niger.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- How many people
- 7,836 participants
- Where
- 1 siteNiger
- Study dates
- Jul 2011to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children 6 to 24 months
Who may be able to join
- resident in selected villages
- height between 60 and 80 cm.
Who cannot join
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Malnutrition
- Keywords
- pediatrics, Ready-to-use Supplementary Food, corn soy blend, cash transfer, prevention of malnutrition, Niger
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe acute malnutrition
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).
Measured: 15 months
Secondary outcomes (1)
Mortality
Mortality events include all reports for which the cause for absence from surveillance visits was reported to be death by a family member.
Measured: duration of follow-up (15 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startJul 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 7,836 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- United Nations World Food Programme (WFP)
- Responsible party
- Sponsor
- Investigators
- Céline Langendorf, MPH, Principal investigator, Epicentre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828814
- Sponsor's protocol ID
- Epicentre
- Status last verified
- Apr 2017
- First submitted
- 4 Mar 2013
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26423742Langendorf 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.
PubMed 25180584
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Strategies for Preventing Severe Acute Malnutrition in Niger: a Pragmatic Trial
- ClinicalTrials.gov ID
- NCT01828814
- Acronym / sponsor ID
- Epicentre
- Conditions
- Malnutrition
- Keywords
- pediatrics, Ready-to-use Supplementary Food, corn soy blend, cash transfer, prevention of malnutrition, Niger
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,836 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- United Nations World Food Programme (WFP)
- Study start
- Jul 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 11 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children 6 to 24 months
Key inclusion criteria (2 listed)
- resident in selected villages
- height between 60 and 80 cm.
Key exclusion criteria (1 listed)
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Mortality
Time frame: duration of follow-up (15 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Derived from this study: PubMed 26423742Sayyad-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.
- Derived from this study: PubMed 25180584Langendorf 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Céline Langendorf, MPH principal investigator
Epicentre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Epicentre at 1 site in Niger.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Niger. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe acute malnutrition (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01828814, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.