MalnutritionPhase 4NRCI-ASPENCT02085044
Non Randomized Controlled Intervention Study Comparing Two Interventions of Nutritional Supplement on Malnutrition, Health and Mortality
A Phase 4 study testing Ready-to-Used Supplement Food administration in people with Malnutrition, run by France Broillet at 1 site in Chad.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 6 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Ready-to-Used Supplement Food administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,700 participants
- Where
- 1 siteChad
- Study dates
- Feb 2012to Dec 2013
- Phase
- Phase 4
- 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
Who may be able to join
- children between 6 months and 24 months of age
Who cannot join
- children who can 't swallow
- children from parents who does not want to be in the study
Trial locations and contacts
1 site in 1 country.
Chad1 site
Médecins Sans Frontières-OCG
Massakory
About this study
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
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).
- Conditions
- Malnutrition
- Being tested
- Ready-to-Used Supplement Food administration
- Keywords
- malnutrition, children's health, prevention, ready-to-use supplementary food, lipid based nutrient supplement, chad, children
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready-to-Used Supplement Food administrationDietary supplement
Also called Plumpy 'doz
| Study group | Role | What they receive |
|---|---|---|
| 12 months RUSF | Experimental | Children between 6 to 24 months received ready-to-used supplementary food every months during the whole year. Receives: Dietary Supplement: Ready-to-Used Supplement Food administration |
| 4 months RUSF | Active comparator | 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) Receives: Dietary Supplement: Ready-to-Used Supplement Food administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute severe malnutrition
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 )
Measured: overall study time, 22 months
Mortality rate
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 )
Measured: overall study time 22 months
Secondary outcomes (3)
Morbidity
Measured: overall study time 22 months
Gain of mid-upper-arm circumference (MUAC) gain
Measured: 22 months
Weight for Height gain
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startFeb 2012
- Primary completionFeb 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- France Broillet
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Tropical & Public Health Institute
- Responsible party
- Sponsor-investigator, France Broillet, Médecins Sans Frontières, Switzerland
- Investigators
- Annick Antierens, Study chair, Medecins Sans Frontieres, NetherlandsFrance Broillet, Principal investigator, Medecins Sans Frontieres, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085044
- Sponsor's protocol ID
- Médecins Sans Frontières-OCG
- Acronym
- NRCI-ASPE
- Status last verified
- Oct 2013
- First submitted
- 26 Feb 2014
- Last updated
- 12 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02085044
- Acronym / sponsor ID
- NRCI-ASPE / Médecins Sans Frontières-OCG
- Conditions
- Malnutrition
- Keywords
- malnutrition, children's health, prevention, ready-to-use supplementary food, lipid based nutrient supplement, chad, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,700 participants (actual)
- Lead sponsor
- France BroilletUniversity, hospital or other
- Collaborators
- Swiss Tropical & Public Health Institute
- Study start
- Feb 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Mar 2014 (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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12 months RUSF | Experimental | Dietary Supplement: Ready-to-Used Supplement Food administrationChildren between 6 to 24 months received ready-to-used supplementary food every months during the whole year. |
| 4 months RUSF | Active comparator | Dietary Supplement: Ready-to-Used Supplement Food administrationchildren 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) |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children between 6 months and 24 months of age
Key exclusion criteria (2 listed)
- children who can 't swallow
- children from parents who does not want to be in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ready-to-Used Supplement Food administrationAlso: Plumpy 'doz | Dietary supplement | 12 months RUSF, 4 months RUSF |
Primary outcome
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 )
3 secondary outcomes
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
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 12 Mar 2014.
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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.
Annick Antierens study chair
Medecins Sans Frontieres, Netherlands
France Broillet principal investigator
Medecins Sans Frontieres, Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ready-to-Used Supplement Food administration in people with Malnutrition, run by France Broillet at 1 site in Chad.
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 1 inclusion and 2 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 12 Mar 2014. 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 Chad. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 acute severe malnutrition (time frame: overall study time, 22 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2014.