Child Acute MalnutritionPhase 4PROMIS-BFNCT02245152
The Effect of Integrated Prevention and Treatment on Child Malnutrition and Health in Burkina Faso: a Cluster Randomized Intervention Study
A Phase 4 study testing LNS, Child's health and nutrition topics and National policy well-baby visits in people with Child Acute Malnutrition, run by International Food Policy Research Institute at 1 site in Burkina Faso.
Trial summary
Globally, child undernutrition is the underlying cause for 3.1 million deaths of children younger than 5 years. 18.7 million children under five years of age suffer from severe acute malnutrition (SAM) and an additional 33 million children suffer from moderate acute malnutrition, and are at risk of developing SAM In… Read more about this study
- Who is it for?
- Ages Up to 17 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Acute Malnutrition
- What is being tested?
- LNS, Child's health and nutrition topics and National policy well-baby visits
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 6 Oct 2014to 1 May 2017
- 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 Up to 17 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- At least one index child 0-17 months of age in the household
- Mother should be living in the study area since the index child's delivery
- Singleton infants
- child 0-1.4 months of age;
- Mother should be living in the study area since the index child's delivery
- Singleton infants
Who cannot join
- Index child should not present congenital deformations that hamper anthropometric measurements
- Longitudinal study (n=2,180)
- Congenital malformations that make anthropometric measurements impossible
- Mother planning to leave the study area in the coming year
- Children of 1.5 month of age or older at study inclusion
- WHZ<-2 both at enrollment and at the first follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Globally, child undernutrition is the underlying cause for 3.1 million deaths of children younger than 5 years. 18.7 million children under five years of age suffer from severe acute malnutrition (SAM) and an additional 33 million children suffer from moderate acute malnutrition, and are at risk of developing SAM
In Sub-Saharan Africa, there is often poor integration between programs to treat child acute malnutrition and programs that focus on the prevention of acute and chronic undernutrition - resulting in many missed opportunities for using prevention platforms to screen and refer SAM children, or for using screening and referral platforms to provide prevention services.
This project will address two critical gaps related to the integration of preventive and treatment programs: 1) screening and treatment of MAM/SAM have not yet been systematically integrated into routine health-center visits or mainstreamed into community outreach programs; and 2) screening programs often do not offer any preventive services for those children found not to be suffering from MAM/SAM at the time of screening; mothers of children identified as non-MAM/SAM case are usually sent home without receiving any health or nutrition inputs and as a result, may fail to come back for screening because they do not see any tangible benefit associated with their participation in the screening. This project will specifically address these gaps by assessing the effect of an integrated approach consisting of higher screening coverage and preventive Behavior Change Communication (BCC) + Small-Quantity Lipid-based Nutrient supplementation (SQ-LNS) on both prevention and treatment of child undernutrition.
Read the detailed description
Because of the intended dual role of BCC/SQ-LNS on child undernutrition in this study - e.g. to help prevent child undernutrition and enhance the coverage of screening, referral and treatment of SAM/MAM, it is necessary to combine two study designs to rigorously evaluate the impact of the proposed intervention and to tease out the contribution of prevention and enhanced coverage/treatment to the overall impact on child malnutrition.
The proposed study will therefore use two types of study designs. The first one is a repeated cross-sectional design that will compare select study outcomes between intervention and control groups at endline, after 24 months of program implementation. A repeated cross-sectional study design among children 0-17 months, at baseline and at study endline (on different children) will be used to assess the impact of the intervention on the prevalence of several outcomes, including the prevalence of MAM/SAM and stunting, the coverage of MAM/SAM screening and maternal ENA/IYCF/WASH knowledge and practices. The second proposed study design entails a longitudinal design whereby individual children will be recruited at birth and followed-up monthly until they reach 18 months of age. We anticipate needing approximately 5 months to recruit the required number of children (estimated at 2,040- 1,020 in the control group and 1,020 in the intervention group). This design will allow us to assess the intervention's effects on the incidence, recovery and recurrence rates of MAM/SAM.
- Conditions
- Child Acute Malnutrition
- Being tested
- LNS, Child's health and nutrition topics, National policy well-baby visits
- Keywords
- child acute malnutrition, prevention, behavior change communication, lipid-based nutrient supplement, screening coverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNSDietary supplement
Also called Lipid-based nutrient supplement (LNS)
A monthly dose of LNS (31 sachets of 20g) will be distributed to mothers attending well-baby visits and participating in small group counseling
Child's health and nutrition topicsBehavioural
After the well-baby visit. Caregivers will be invited to participate in a small group counseling or BCC (2-3 caregivers at a time).
Every month a set of topics related to child's health and nutrition will be treated. These BCC sessions will be organized in an interactive way centering around the condition of the participating children.
National policy well-baby visitsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| PROMIS intervention | Experimental | * Small group behavior change communication (BCC) on Essential Nutrition Actions (ENA), Infant and Young Child Feeding (IYCF) and Water, sanitation and hygiene (WASH) is provided during monthly well-baby visits for children 0-17 months of age
* Caregivers with children 0-17 months of age that attend the well-baby visit will be provided with a monthly dose of LNS (20g/day) Receives: Dietary Supplement: LNS; Behavioral: Child's health and nutrition topics; Behavioral: National policy well-baby visits |
| control | Active comparator | Monthly well-baby visits as prescribed by national policy This arm is the basic comparison arm. Caregivers are invited to frequent the health center once a month for well-baby visits. During these visits necessary vaccinations are administered, child growth and nutrition status is evaluated and preventive counseling on child nutrition and health is provided in large groups of caregivers. Receives: Behavioral: National policy well-baby visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 0-17 months of age
- Cross-sectional study
- To calculate WHZ scores the 2006 WHO growth reference will be used
- The MUAC criterion (125mm) is only used for children 6-17months of age
Measured: After 24 months of program implementation
Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 0-17 months)
- Cross-sectional study
- Longitudinal study
Measured: monthly from study inclusion at 0 months to 17 months of age and at study endline
Incidence of child acute malnutrition defined by WHZ<-2 or MUAC<125mm
- Longitudinal study
- To calculate WHZ scores the 2006 WHO growth reference will be used
Measured: monthly from study inclusion at 0 months to 17 months of age
Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted)
- Cross-sectional study
- Longitudinal study
Measured: monthly from study inclusion at 0 months to 17 months of age and at study endline
Secondary outcomes (16)
Prevalence of child stunting defined by HAZ<-2 in children 0-17 months of age
To calculate HAZ scores the 2006 WHO growth reference will be used
Measured: After 24 months of program implementation
Mean WHZ-score in children 0 -17 months of age
To calculate WHZ scores the 2006 WHO growth reference will be used
Measured: After 24 months of program implementation
Mean HAZ-score in children 0-17 months of age
To calculate HAZ scores the 2006 WHO growth reference will be used
Measured: After 24 months of program implementation
Mean mid-upper arm circumference in children 0-17 months of age
Measured: After 24 months of program implementation
Mean hemoglobin concentration in children 3-17 months of age
Hemocues will be used to measure Hb concentration
Measured: After 24 months of program implementation
Prevalence of child anemia (Hb concentration<10g/dL) in children 3 - 17 months of age
Measured: After 24 months of program implementation
Prevalence of severe acute child malnutrition defined by a WHZ<-3 or bilateral pitting edema or a MUAC<115mm in children 0-17 months of age
The MUAC criterion (115mm) is only used for children 6-17months of age
Measured: After 24 months of program implementation
Prevalence of severe stunting defined by a HAZ<-3 in children 0-17 months of age
To calculate HAZ scores the 2006 WHO growth reference will be used
Measured: After 24 months of program implementation
Caregiver's knowledge and practices related to Infant and Young Child Feeding (IYCF), Essential Nutrition Actions (ENA) and Water, Sanitation and Hygiene (WASH)
Measured: After 24 months of program implementation
Incidence of child stunting defined by HAZ<-2 in children from 0 to 17 months
To calculate HAZ score the 2006 WHO growth reference will be used
Measured: monthly from inclusion at 0 months to 17 months of age
Linear growth velocity (HAZ increment/month)
To calculate HAZ score the 2006 WHO growth reference will be used
Measured: monthly from inclusion at 0 months to 17 months of age
Ponderal growth velocity (WHZ increment/month)
To calculate WHZ score the 2006 WHO growth reference will be used
Measured: monthly from inclusion at 0 months to 17 months of age
Weight gain (weight increment/month)
Measured: monthly from inclusion at 0 months to 17 months of age
Mid-upper arm circumference gain (MUAC increment/month)
Measured: monthly from inclusion at 0 months to 17 moths of age
Infant morbidity (acute respiratory infections, fever, malaria (RDT), vomiting, diarrhea)
Malaria will be tested in case of fever (or recalled fever over last 24hrs) use rapid tests
Measured: monthly from inclusion at 0 months to 17 moths of age
Relapse rate after treatment of MAM/SAM (proportion WHZ<-2 or MUAC<125mm or bilateral pitting edema after discharge from MAM or SAM treatment program over total number of children treated)
Measured: monthly from inclusion at 0 months to 17 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study start6 Oct 2014
- Primary completionMar 2017
- Study completion1 May 2017
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 Child Acute 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Helen Keller International
- Responsible party
- Sponsor
- Investigators
- Marie Ruel, PhD, Principal investigator, International Food Policy Research InstituteJean-Celestin Somda, MD, Principal investigator, Helen Keller International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245152
- Sponsor's protocol ID
- IFPRI-2014-001
- Other IDs
- DFATD
- Acronym
- PROMIS-BF
- Status last verified
- Mar 2017
- First submitted
- 16 Sep 2014
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Becquey E, Huybregts L, Zongrone A, Le Port A, Leroy JL, Rawat R, Toure M, Ruel MT. Impact on child acute malnutrition of integrating a preventive nutrition package into facility-based screening for acute malnutrition during well-baby consultation: A cluster-randomized controlled trial in Burkina Faso. PLoS Med. 2019 Aug 27;16(8):e1002877. doi: 10.1371/journal.pmed.1002877. eCollection 2019 Aug.
PubMed 31454347Huybregts L, Becquey E, Zongrone A, Le Port A, Khassanova R, Coulibaly L, Leroy JL, Rawat R, Ruel MT. The impact of integrated prevention and treatment on child malnutrition and health: the PROMIS project, a randomized control trial in Burkina Faso and Mali. BMC Public Health. 2017 Mar 9;17(1):237. doi: 10.1186/s12889-017-4146-6.
PubMed 28274214
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Integrated Prevention and Treatment on Child Malnutrition and Health in Burkina Faso: a Cluster Randomized Intervention Study
- ClinicalTrials.gov ID
- NCT02245152
- Acronym / sponsor ID
- PROMIS-BF / IFPRI-2014-001
- Conditions
- Child Acute Malnutrition
- Keywords
- child acute malnutrition, prevention, behavior change communication, lipid-based nutrient supplement, screening coverage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- Helen Keller International
- Study start
- 6 Oct 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 19 Sep 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.
Globally, child undernutrition is the underlying cause for 3.1 million deaths of children younger than 5 years. 18.7 million children under five years of age suffer from severe acute malnutrition (SAM) and an additional 33 million children suffer from moderate acute malnutrition, and are at risk of developing SAM
In Sub-Saharan Africa, there is often poor integration between programs to treat child acute malnutrition and programs that focus on the prevention of acute and chronic undernutrition - resulting in many missed opportunities for using prevention platforms to screen and refer SAM children, or for using screening and referral platforms to provide prevention services.
This project will address two critical gaps related to the integration of preventive and treatment programs: 1) screening and treatment of MAM/SAM have not yet been systematically integrated into routine health-center visits or mainstreamed into community outreach programs; and 2) screening programs often do not offer any preventive services for those children found not to be suffering from MAM/SAM at the time of screening; mothers of children identified as non-MAM/SAM case are usually sent home without receiving any health or nutrition inputs and as a result, may fail to come back for screening because they do not see any tangible benefit associated with their participation in the screening. This project will specifically address these gaps by assessing the effect of an integrated approach consisting of higher screening coverage and preventive Behavior Change Communication (BCC) + Small-Quantity Lipid-based Nutrient supplementation (SQ-LNS) on both prevention and treatment of child undernutrition.
Detailed description
Because of the intended dual role of BCC/SQ-LNS on child undernutrition in this study - e.g. to help prevent child undernutrition and enhance the coverage of screening, referral and treatment of SAM/MAM, it is necessary to combine two study designs to rigorously evaluate the impact of the proposed intervention and to tease out the contribution of prevention and enhanced coverage/treatment to the overall impact on child malnutrition.
The proposed study will therefore use two types of study designs. The first one is a repeated cross-sectional design that will compare select study outcomes between intervention and control groups at endline, after 24 months of program implementation. A repeated cross-sectional study design among children 0-17 months, at baseline and at study endline (on different children) will be used to assess the impact of the intervention on the prevalence of several outcomes, including the prevalence of MAM/SAM and stunting, the coverage of MAM/SAM screening and maternal ENA/IYCF/WASH knowledge and practices. The second proposed study design entails a longitudinal design whereby individual children will be recruited at birth and followed-up monthly until they reach 18 months of age. We anticipate needing approximately 5 months to recruit the required number of children (estimated at 2,040- 1,020 in the control group and 1,020 in the intervention group). This design will allow us to assess the intervention's effects on the incidence, recovery and recurrence rates of MAM/SAM.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROMIS intervention | Experimental | Dietary Supplement: LNS, Behavioral: Child's health and nutrition topics, Behavioral: National policy well-baby visits* Small group behavior change communication (BCC) on Essential Nutrition Actions (ENA), Infant and Young Child Feeding (IYCF) and Water, sanitation and hygiene (WASH) is provided during monthly well-baby visits for children 0-17 months of age * Caregivers with children 0-17 months of age that attend the well-baby visit will be provided with a monthly dose of LNS (20g/day) |
| control | Active comparator | Behavioral: National policy well-baby visitsMonthly well-baby visits as prescribed by national policy This arm is the basic comparison arm. Caregivers are invited to frequent the health center once a month for well-baby visits. During these visits necessary vaccinations are administered, child growth and nutrition status is evaluated and preventive counseling on child nutrition and health is provided in large groups of caregivers. |
Who may qualify
- Ages
- Up to 17 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- At least one index child 0-17 months of age in the household
- Mother should be living in the study area since the index child's delivery
- Singleton infants
- child 0-1.4 months of age;
- Mother should be living in the study area since the index child's delivery
Key exclusion criteria (6 listed)
- Index child should not present congenital deformations that hamper anthropometric measurements
- Longitudinal study (n=2,180)
- Congenital malformations that make anthropometric measurements impossible
- Mother planning to leave the study area in the coming year
- Children of 1.5 month of age or older at study inclusion
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 |
|---|---|---|
| LNSAlso: Lipid-based nutrient supplement (LNS)A monthly dose of LNS (31 sachets of 20g) will be distributed to mothers attending well-baby visits and participating in small group counseling | Dietary supplement | PROMIS intervention |
| Child's health and nutrition topicsAfter the well-baby visit. Caregivers will be invited to participate in a small group counseling or BCC (2-3 caregivers at a time). Every month a set of topics related to child's health and nutrition will be treated. These BCC sessions will be organized in an interactive way centering around the condition of the participating children. | Behavioural | PROMIS intervention |
| National policy well-baby visits | Behavioural | PROMIS intervention, control |
Primary outcome
Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 0-17 months of age
Time frame: After 24 months of program implementation
* Cross-sectional study * To calculate WHZ scores the 2006 WHO growth reference will be used * The MUAC criterion (125mm) is only used for children 6-17months of age
Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 0-17 months)
Time frame: monthly from study inclusion at 0 months to 17 months of age and at study endline
* Cross-sectional study * Longitudinal study
Incidence of child acute malnutrition defined by WHZ<-2 or MUAC<125mm
Time frame: monthly from study inclusion at 0 months to 17 months of age
* Longitudinal study * To calculate WHZ scores the 2006 WHO growth reference will be used
Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted)
Time frame: monthly from study inclusion at 0 months to 17 months of age and at study endline
* Cross-sectional study * Longitudinal study
16 secondary outcomes
Prevalence of child stunting defined by HAZ<-2 in children 0-17 months of age
Time frame: After 24 months of program implementation
Mean WHZ-score in children 0 -17 months of age
Time frame: After 24 months of program implementation
Mean HAZ-score in children 0-17 months of age
Time frame: After 24 months of program implementation
Mean mid-upper arm circumference in children 0-17 months of age
Time frame: After 24 months of program implementation
Mean hemoglobin concentration in children 3-17 months of age
Time frame: After 24 months of program implementation
Prevalence of child anemia (Hb concentration<10g/dL) in children 3 - 17 months of age
Time frame: After 24 months of program implementation
Prevalence of severe acute child malnutrition defined by a WHZ<-3 or bilateral pitting edema or a MUAC<115mm in children 0-17 months of age
Time frame: After 24 months of program implementation
Prevalence of severe stunting defined by a HAZ<-3 in children 0-17 months of age
Time frame: After 24 months of program implementation
Caregiver's knowledge and practices related to Infant and Young Child Feeding (IYCF), Essential Nutrition Actions (ENA) and Water, Sanitation and Hygiene (WASH)
Time frame: After 24 months of program implementation
Incidence of child stunting defined by HAZ<-2 in children from 0 to 17 months
Time frame: monthly from inclusion at 0 months to 17 months of age
Linear growth velocity (HAZ increment/month)
Time frame: monthly from inclusion at 0 months to 17 months of age
Ponderal growth velocity (WHZ increment/month)
Time frame: monthly from inclusion at 0 months to 17 months of age
Weight gain (weight increment/month)
Time frame: monthly from inclusion at 0 months to 17 months of age
Mid-upper arm circumference gain (MUAC increment/month)
Time frame: monthly from inclusion at 0 months to 17 moths of age
Infant morbidity (acute respiratory infections, fever, malaria (RDT), vomiting, diarrhea)
Time frame: monthly from inclusion at 0 months to 17 moths of age
Relapse rate after treatment of MAM/SAM (proportion WHZ<-2 or MUAC<125mm or bilateral pitting edema after discharge from MAM or SAM treatment program over total number of children treated)
Time frame: monthly from inclusion at 0 months to 17 months of age
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 9 Mar 2018.
- Derived from this study: PubMed 31454347Becquey E, Huybregts L, Zongrone A, Le Port A, Leroy JL, Rawat R, Toure M, Ruel MT. Impact on child acute malnutrition of integrating a preventive nutrition package into facility-based screening for acute malnutrition during well-baby consultation: A cluster-randomized controlled trial in Burkina Faso. PLoS Med. 2019 Aug 27;16(8):e1002877. doi: 10.1371/journal.pmed.1002877. eCollection 2019 Aug.
- Derived from this study: PubMed 28274214Huybregts L, Becquey E, Zongrone A, Le Port A, Khassanova R, Coulibaly L, Leroy JL, Rawat R, Ruel MT. The impact of integrated prevention and treatment on child malnutrition and health: the PROMIS project, a randomized control trial in Burkina Faso and Mali. BMC Public Health. 2017 Mar 9;17(1):237. doi: 10.1186/s12889-017-4146-6.
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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.
Marie Ruel, PhD principal investigator
International Food Policy Research Institute
Jean-Celestin Somda, MD principal investigator
Helen Keller International
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 LNS, Child's health and nutrition topics and National policy well-baby visits in people with Child Acute Malnutrition, run by International Food Policy Research Institute 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 6 inclusion and 6 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 9 Mar 2018. 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.
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?
Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 0-17 months of age (time frame: After 24 months of program implementation). The study lists 4 primary outcomes in all. 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 NCT02245152, 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 9 Mar 2018.