Global Acute Malnutrition (GAM)MUAC-OnlyNCT03027505
Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Burkina Faso
A study testing Ready to Use Therapeutic Food (RUTF) in people with Global Acute Malnutrition (GAM), run by Alliance for International Medical Action at 1 site in Burkina Faso.
Trial summary
MUAC only is a pilot trial external control carried out between January 2017 and December 2017 in the Yako district (northern region), Burkina Faso. The objective of this study is to evaluate an integrated protocol for acute malnourished children without medical complication. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Global Acute Malnutrition (GAM)
- What is being tested?
- Ready to Use Therapeutic Food (RUTF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,958 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Jan 2017to Apr 2018
- Phase
- Interventional
- 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 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being between 6 and 59 months old
- New admission
- Acute malnutrition defined as follows:
- MUAC<125mm
- MUAC> 125mm AND WHZ (Z-score) <-3 (WHO standard)
- Edema
- Resident in the study area (Yako district)
- Signed informed consent of the mother or the child's guardian
Who cannot join
- Children allergic to milk, peanuts and / or RUTF
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Passore Province (Northern Region), Burkina Faso
MUAC only is a pilot trial external control carried out between January 2017 and December 2017 in the Yako district (northern region), Burkina Faso.
The objective of this study is to evaluate an integrated protocol for acute malnourished children without medical complication. The hypotheses of the integrated protocol include :
- A global treatment of acute malnutrition (moderate and severe) with a single treatment (RUTF) would improve the functioning of the program through early identification of acutely malnourished children, while achieving a better coverage and using a single supply chain.
- A gradual reduction of RUTF dosage according to a child's MUAC status could significantly increase the number of children on treatment without increasing overall RUTF quantity while maintaining similar recovery rates.
Read the detailed description
Objectives :
Main objective :
To ensure the recovery rate of the integrated protocol for treatment of acute malnutrition is significantly greater than 75% (reference value of the national program in BF).
Secondary objectives :
- To ensure the mortality rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 3% (reference value of the national BF program).
- To ensure the default rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 15% (reference value of the national BF program).
- To ensure the non-response rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 8%.
- To ensure the hospitalization rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 15%.
- To ensure the coverage rate of the program increases by 30% after the year the integrated protocol was introduced (specific protocol annexed).
- To estimate the relapse rate of the integrated protocol for treatment of acute malnutrition.
- To compare RUTF rations per child of the integrated protocol compared to the national protocol
Methods :
The study population will include all acutely malnourished children aged between 6 and 59 months seeking consultations at all of the health centers in Yako District between January 2017 and December 2017.
The study will be implemented in Burkina Faso's Yako District, which includes 54 health centers.
- Conditions
- Global Acute Malnutrition (GAM)
- Being tested
- Ready to Use Therapeutic Food (RUTF)
- Keywords
- MUAC, Acute malnutrition, RUTF, Children, Burkina Faso
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready to Use Therapeutic Food (RUTF)Drug
Also called MUAC<125mm
MUAC used as the primary admission and exit criteria for children with MUAC <125mm and no medical complication.
Single treatment of RUTF for severe and moderate malnourished children and gradual reduction of doses according to the MUAC and the weight of the child during treatment. MUAC split into 3 categories:
- MUAC <115 mm: 175 kcal /kg/day
- 115 <MUAC <120mm: 125kcal/kg/day
- 120 <MUAC <125mm: 75kcal/kg/day
| Study group | Role | What they receive |
|---|---|---|
| MUAC<125mm | Experimental | no medical complication Receives: Drug: Ready to Use Therapeutic Food (RUTF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery rate
The recovery is defined as below :
- Minimum of 4 weeks of participation in the program
- MUAC> = 125 mm on 2 consecutive visits
- No edema for minimum 2 weeks
- Good Clinical Health
Measured: Between 4 and 12 weeks
Secondary outcomes (6)
Mortality rate
Measured: Between inclusion and week 12
Default rate
Patient absent for 3 consecutive visits
Measured: Between 3 and 12 weeks
Non-respondent rate
Patient who not reach the recovery criteria after twelve weeks in the program
Measured: 12 weeks after inclusion
Hospitalization rate
Measured: Between inclusion and week 12
Relapse rate
Patient having reached the recovery criteria and returning for a new episode of malnutrition (MUAC<125mm).
The children's MUAC will be measured at home 3 months after program exit. For organizational and financial reasons, this data will not be collected for all children. A specific protocol explaining the sampling and organization of data collection will be annexed to the protocol.
Measured: up to 3 months
RUTF rations
Total number of RUTF bags received per child during participation in the program.
Measured: Between inclusion and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Global Acute Malnutrition (GAM)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,958 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for International Medical Action
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Association Keoogo, Institut de Recherche en Sciences de la Sante, Burkina Faso, SOS médecins Burkina Faso
- Responsible party
- Sponsor
- Investigators
- Susan Shepherd, MD, Principal investigator, Directrice de recherches Opérationnelles et Médicales, ALIMA, USARenaud Becquet, MPH,PhD,HDR, Principal investigator, Chercheur Inserm, Inserm U1219 Bordeaux Population Health Center-Université de Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027505
- Sponsor's protocol ID
- MUAC Only Burkina Faso
- Acronym
- MUAC-Only
- Status last verified
- Jan 2019
- First submitted
- 17 Jan 2017
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Passore Province (Northern Region), Burkina Faso
- ClinicalTrials.gov ID
- NCT03027505
- Acronym / sponsor ID
- MUAC-Only / MUAC Only Burkina Faso
- Conditions
- Global Acute Malnutrition (GAM)
- Keywords
- MUAC, Acute malnutrition, RUTF, Children, Burkina Faso
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,958 participants (actual)
- Lead sponsor
- Alliance for International Medical ActionUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Association Keoogo, Institut de Recherche en Sciences de la Sante, Burkina Faso, SOS médecins Burkina Faso
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 23 Jan 2017 (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.
MUAC only is a pilot trial external control carried out between January 2017 and December 2017 in the Yako district (northern region), Burkina Faso.
The objective of this study is to evaluate an integrated protocol for acute malnourished children without medical complication. The hypotheses of the integrated protocol include :
- A global treatment of acute malnutrition (moderate and severe) with a single treatment (RUTF) would improve the functioning of the program through early identification of acutely malnourished children, while achieving a better coverage and using a single supply chain.
- A gradual reduction of RUTF dosage according to a child's MUAC status could significantly increase the number of children on treatment without increasing overall RUTF quantity while maintaining similar recovery rates.
Detailed description
Objectives :
Main objective :
To ensure the recovery rate of the integrated protocol for treatment of acute malnutrition is significantly greater than 75% (reference value of the national program in BF).
Secondary objectives :
- To ensure the mortality rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 3% (reference value of the national BF program).
- To ensure the default rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 15% (reference value of the national BF program).
- To ensure the non-response rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 8%.
- To ensure the hospitalization rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 15%.
- To ensure the coverage rate of the program increases by 30% after the year the integrated protocol was introduced (specific protocol annexed).
- To estimate the relapse rate of the integrated protocol for treatment of acute malnutrition.
- To compare RUTF rations per child of the integrated protocol compared to the national protocol
Methods :
The study population will include all acutely malnourished children aged between 6 and 59 months seeking consultations at all of the health centers in Yako District between January 2017 and December 2017.
The study will be implemented in Burkina Faso's Yako District, which includes 54 health centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MUAC<125mm | Experimental | Drug: Ready to Use Therapeutic Food (RUTF)no medical complication |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Being between 6 and 59 months old
- New admission
- Acute malnutrition defined as follows:
- Resident in the study area (Yako district)
- Signed informed consent of the mother or the child's guardian
Key exclusion criteria (1 listed)
- Children allergic to milk, peanuts and / or RUTF
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 Use Therapeutic Food (RUTF)Also: MUAC<125mmMUAC used as the primary admission and exit criteria for children with MUAC <125mm and no medical complication. Single treatment of RUTF for severe and moderate malnourished children and gradual reduction of doses according to the MUAC and the weight of the child during treatment. MUAC split into 3 categories: * MUAC <115 mm: 175 kcal /kg/day * 115 <MUAC <120mm: 125kcal/kg/day * 120 <MUAC <125mm: 75kcal/kg/day | Drug | MUAC<125mm |
Primary outcome
Recovery rate
Time frame: Between 4 and 12 weeks
The recovery is defined as below : * Minimum of 4 weeks of participation in the program * MUAC> = 125 mm on 2 consecutive visits * No edema for minimum 2 weeks * Good Clinical Health
6 secondary outcomes
Mortality rate
Time frame: Between inclusion and week 12
Default rate
Time frame: Between 3 and 12 weeks
Non-respondent rate
Time frame: 12 weeks after inclusion
Hospitalization rate
Time frame: Between inclusion and week 12
Relapse rate
Time frame: up to 3 months
RUTF rations
Time frame: Between inclusion and week 12
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 30 Jan 2019.
- Individual participant dataSharing planned: No
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.
Susan Shepherd, MD principal investigator
Directrice de recherches Opérationnelles et Médicales, ALIMA, USA
Renaud Becquet, MPH,PhD,HDR principal investigator
Chercheur Inserm, Inserm U1219 Bordeaux Population Health Center-Université de Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ready to Use Therapeutic Food (RUTF) in people with Global Acute Malnutrition (GAM), run by Alliance for International Medical Action at 1 site in Burkina Faso.
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 8 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 30 Jan 2019. 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 Burkina Faso. 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?
Recovery rate (time frame: Between 4 and 12 weeks). 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 30 Jan 2019.