Growth FailureNCT05121935
MAL-ED Metabolic: A Follow-Up of Chronic Disease at Puberty
An observational study of Growth Failure and Intestinal Infection, run by University of Virginia.
Trial summary
The concept that the roots of cardiometabolic disease start in early life was established by Dr. David Barker, who documented relationships between low birthweight (as a marker for challenges during gestation) and later cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Growth Failure, Intestinal Infection, Metabolic Syndrome
- How many people
- 254 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to 1 Feb 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 9 to 17 years
- All sexes
- Child
Study population: This is a follow-up study of children who were originally in the MAL-ED cohort.
Who may be able to join
- Participated in original MAL-ED cohort
Who cannot join
- Did not participate in original MAL-ED cohort
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The concept that the roots of cardiometabolic disease start in early life was established by Dr. David Barker, who documented relationships between low birthweight (as a marker for challenges during gestation) and later cardiovascular disease (CVD). Later work has suggested that post-natal challenges (similar to prenatal ones) may also exhibit links to later cardiometabolic disease, with the strongest links appearing to be between low weight in early childhood and later hypertension and high waist circumference (WC). However, assessments for the relationship between early childhood challenges and insulin resistance and glucose regulation have been lacking and long-term cohort studies are few. In this project, we aim to assess children initially followed as part of The Etiology, Risk Factors, and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health (MAL-ED) study, where they received frequent measures of anthropometry and laboratory assessments for intestinal pathogens. These children are now of peri-pubertal age--a time period associated with metabolic shifts. We will assess for glucose dysregulation and findings associated with the metabolic syndrome, and we will analyze potential associations between current chronic disease risk findings with early life poor growth and intestinal pathogen carriage rate. As such, we hope to uncover potential targets in early life health to reduce later chronic disease risk.
Read the detailed description
The relationship between prenatal challenges and later risk for chronic disease has been well established. Our group previously assessed the hypothesis that post-natal challenges (similar to prenatal ones) would exhibit links to later cardiometabolic disease. This was performed using retrospective data from a long-term cohort of children in Guatemala, demonstrating novel findings that higher degrees of diarrhea burden in the first 6 months of life (as a marker of nutritional and/or inflammatory stressors) were associated with a greater risk of metabolic syndrome as adults The causes of these findings are not known, though postulated mechanisms include epigenetic reprograming of metabolic rate, hormonal regulation and vascular tone. Unfortunately, long-term cohort studies are few, limiting opportunities to evaluate these links prospectively.
The Haydom Global Health Research Center in north central Tanzania represents an important rural setting for performing high-quality medical research in sub-Saharan Africa (5). The region around Haydom has a high degree of stunting and enteric pathogen carriage among a cohort of children followed in the area from 2009-2013 as part of the multi-country study "The Etiology, Risk Factors, and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health (MAL-ED)."
These children followed in Haydom during MAL-ED had monthly anthropometry and stool pathogen analysis, as well as extensive demographic data. This provides an opportunity to follow up on these children to assess for potential links between early life challenges (both enteric disease, infections and nutritional deficiencies) and later chronic disease risk, including lipid abnormalities, glucose intolerance and blood pressure elevations. The current proposal is to follow up on these children at the age of typical entry into puberty, as this is a common shift in metabolism when many children begin to exhibit metabolic abnormalities. We will assess these children for multiple measures:
- Anthropometry (height, weight, BMI, waist circumference)
- Assessment of pubertal stage by exam or questionnaire
- Blood pressure
- Lipids (LDL, HDL, triglycerides)
- CRP
- Oral glucose tolerance test (OGTT)
- Fasting insulin
- Metabolic syndrome (MetS) severity score
- Blood saved for future epigenetic testing
We will use linear and and logistic regression to determine associations between 1) mean number of monthly pathogens (individual pathogens and in aggregate) and 2) reported symptoms (fever, cough, diarrhea), with multiple MetS-related outcomes: BMI percentile, WC, fasting insulin, 2-hour glucose following OGTT, triglycerides, HDL cholesterol, normalized BP and a MetS diagnosis.
The underlying hypothesis is that there will be consistent links between features of MetS (in particular blood pressure, waist circumference and insulin resistance) with 1) enteric pathogen burden (overall and for particularly virulent pathogens such as Enterotoxigenic E.coli) and 2) poor early life growth.
- Medical subject headings
- Failure to Thrive, Metabolic Syndrome, Glucose Intolerance
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 |
|---|---|---|
| MAL-ED cohort | Children initially followed from birth through 2 years old in the MAL-ED study (with some additional assessments in follow-up studies since then). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current Systolic BP--relationship to number of enteric pathogens by age 2 years
Regression analysis of current systolic BP z-score vs. number enteric pathogens by age 2 years (from MAL-ED)
Measured: Measured during current study (1 year +/- 3 months)
Secondary outcomes (15)
Current Systolic BP--relationship to BMI z-score at age 2 years
Regression analysis of current systolic BP z-score vs. BMI z-score at age 2 years (from MAL-ED), adjusted for current BMI z-score
Measured: Measured during current study (1 year +/- 3 months)
Current Diastolic BP--relationship to number of enteric pathogens by age 2 years
Regression analysis of current diastolic BP z-score vs. number enteric pathogens by age 2 years (from MAL-ED)
Measured: Measured during current study (1 year +/- 3 months)
Current Diastolic BP--relationship to BMI z-score at age 2 years
Regression analysis of current diastolic BP z-score vs. BMI z-score at age 2 years (from MAL-ED), adjusted for current BMI z-score
Measured: Measured during current study (1 year +/- 3 months)
Current BMI z-score--relationship to number of enteric pathogens by age 2 years
Regression analysis of current BMI z-score vs. number enteric pathogens by age 2 years (from MAL-ED)
Measured: Measured during current study (1 year +/- 3 months)
Current waist circumference--relationship to number of enteric pathogens by age 2 years
Regression analysis of current waist circumference vs. number enteric pathogens by age 2 years (from MAL-ED)
Measured: Measured during current study (1 year +/- 3 months)
Metabolic syndrome (MetS) severity score--relationship to number of enteric pathogens by age 2 years
Regression analysis of current MetS severity z-score vs. number enteric pathogens by age 2 years (from MAL-ED)
Measured: Measured during current study (1 year +/- 3 months)
Current metabolic syndrome (MetS) severity score--relationship to BMI z-score at age 2 years
Regression analysis of current MetS severity z-score vs. number enteric pathogens by age 2 years (from MAL-ED), adjusted by current waist circumference
Measured: Measured during current study (1 year +/- 3 months)
Current glucose from oral glucose tolerance test (OGTT) at 2 hours--relationship to number of enteric pathogens by age 2 years
Regression analysis of current 2-hour OGTT glucose vs. number enteric pathogens by age 2 years (from MAL-ED)
Measured: Measured during current study (1 year +/- 3 months)
Current glucose from oral glucose tolerance test (OGTT) at 2 hours--relationship to BMI z-score at age 2 years
Regression analysis of current 2-hour OGTT glucose vs. BMI z-score at age 2 years (from MAL-ED), adjusted by current BMI z-score
Measured: Measured during current study (1 year +/- 3 months)
Current fasting triglycerides--relationship to number of enteric pathogens by age 2 years
Regression analysis of current ln(triglycerides) vs. number enteric pathogens by age 2 years (from MAL-ED)
Measured: Measured during current study (1 year +/- 3 months)
Current fasting triglycerides--relationship to BMI z-score at age 2 years
Regression analysis of current ln(triglycerides) vs. BMI z-score at age 2 years (from MAL-ED), adjusted by current BMI z-score
Measured: Measured during current study (1 year +/- 3 months)
Current HDL cholesterol--relationship to number of enteric pathogens by age 2 years
Regression analysis of current HDL cholesterol vs. number enteric pathogens by age 2 years (from MAL-ED)
Measured: Measured during current study (1 year +/- 3 months)
Current HDL cholesterol--relationship to BMI z-score at age 2 years
Regression analysis of current HDL cholesterol vs. BMI z-score at age 2 years (from MAL-ED), adjusted by current BMI z-score
Measured: Measured during current study (1 year +/- 3 months)
Current fasting glucose--relationship to number of enteric pathogens by age 2 years
Regression analysis of current fasting glucose vs. number enteric pathogens by age 2 years (from MAL-ED)
Measured: Measured during current study (1 year +/- 3 months)
Current fasting glucose--relationship to BMI z-score at age 2 years
Regression analysis of current fasting glucose vs. BMI z-score at age 2 years (from MAL-ED), adjusted by current BMI z-score
Measured: Measured during current study (1 year +/- 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start1 Feb 2022 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Growth FailureStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Haydom Lutheran Hospital
- Responsible party
- Principal investigator, Mark D. DeBoer, MD, MSc., MCR, University of Virginia
- Investigators
- Mark D DeBoer, MD, Principal investigator, University of VirginiaEstomih Mduma, MPH, Study director, Haydom Global Health Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121935
- Sponsor's protocol ID
- 200340
- Status last verified
- Nov 2021
- First submitted
- 3 Nov 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
DeBoer MD, Lima AA, Oria RB, Scharf RJ, Moore SR, Luna MA, Guerrant RL. Early childhood growth failure and the developmental origins of adult disease: do enteric infections and malnutrition increase risk for the metabolic syndrome? Nutr Rev. 2012 Nov;70(11):642-53. doi: 10.1111/j.1753-4887.2012.00543.x.
PubMed 23110643DeBoer MD, Chen D, Burt DR, Ramirez-Zea M, Guerrant RL, Stein AD, Martorell R, Luna MA. Early childhood diarrhea and cardiometabolic risk factors in adulthood: the Institute of Nutrition of Central America and Panama Nutritional Supplementation Longitudinal Study. Ann Epidemiol. 2013 Jun;23(6):314-20. doi: 10.1016/j.annepidem.2013.03.012. Epub 2013 Apr 19.
PubMed 23608305Mduma ER, Gratz J, Patil C, Matson K, Dakay M, Liu S, Pascal J, McQuillin L, Mighay E, Hinken E, Ernst A, Amour C, Mvungi R, Bayyo E, Zakaria Y, Kivuyo S, Houpt ER, Svensen E. The etiology, risk factors, and interactions of enteric infections and malnutrition and the consequences for child health and development study (MAL-ED): description of the Tanzanian site. Clin Infect Dis. 2014 Nov 1;59 Suppl 4:S325-30. doi: 10.1093/cid/ciu439.
PubMed 25305305Scharf RJ, Rogawski ET, Murray-Kolb LE, Maphula A, Svensen E, Tofail F, Rasheed M, Abreu C, Vasquez AO, Shrestha R, Pendergast L, Mduma E, Koshy B, Conaway MR, Platts-Mills JA, Guerrant RL, DeBoer MD. Early childhood growth and cognitive outcomes: Findings from the MAL-ED study. Matern Child Nutr. 2018 Jul;14(3):e12584. doi: 10.1111/mcn.12584. Epub 2018 Feb 2.
PubMed 29392824Nemati K, Michael YZ, Hhando BP, Jatosh S, Houpt ER, Mduma E, DeBoer MD. Catch-up growth following early-life stunting in a low-resource area in rural Tanzania: the MAL-ED Metabolic study. BMJ Open. 2025 Aug 21;15(8):e100955. doi: 10.1136/bmjopen-2025-100955.
PubMed 40840991
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAL-ED Metabolic: A Follow-Up of Chronic Disease at Puberty
- ClinicalTrials.gov ID
- NCT05121935
- Acronym / sponsor ID
- 200340
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Haydom Lutheran Hospital
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Feb 2031 (estimated)
- First posted
- 16 Nov 2021 (actual)
- 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 concept that the roots of cardiometabolic disease start in early life was established by Dr. David Barker, who documented relationships between low birthweight (as a marker for challenges during gestation) and later cardiovascular disease (CVD). Later work has suggested that post-natal challenges (similar to prenatal ones) may also exhibit links to later cardiometabolic disease, with the strongest links appearing to be between low weight in early childhood and later hypertension and high waist circumference (WC). However, assessments for the relationship between early childhood challenges and insulin resistance and glucose regulation have been lacking and long-term cohort studies are few. In this project, we aim to assess children initially followed as part of The Etiology, Risk Factors, and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health (MAL-ED) study, where they received frequent measures of anthropometry and laboratory assessments for intestinal pathogens. These children are now of peri-pubertal age--a time period associated with metabolic shifts. We will assess for glucose dysregulation and findings associated with the metabolic syndrome, and we will analyze potential associations between current chronic disease risk findings with early life poor growth and intestinal pathogen carriage rate. As such, we hope to uncover potential targets in early life health to reduce later chronic disease risk.
Detailed description
The relationship between prenatal challenges and later risk for chronic disease has been well established. Our group previously assessed the hypothesis that post-natal challenges (similar to prenatal ones) would exhibit links to later cardiometabolic disease. This was performed using retrospective data from a long-term cohort of children in Guatemala, demonstrating novel findings that higher degrees of diarrhea burden in the first 6 months of life (as a marker of nutritional and/or inflammatory stressors) were associated with a greater risk of metabolic syndrome as adults The causes of these findings are not known, though postulated mechanisms include epigenetic reprograming of metabolic rate, hormonal regulation and vascular tone. Unfortunately, long-term cohort studies are few, limiting opportunities to evaluate these links prospectively.
The Haydom Global Health Research Center in north central Tanzania represents an important rural setting for performing high-quality medical research in sub-Saharan Africa (5). The region around Haydom has a high degree of stunting and enteric pathogen carriage among a cohort of children followed in the area from 2009-2013 as part of the multi-country study "The Etiology, Risk Factors, and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health (MAL-ED)."
These children followed in Haydom during MAL-ED had monthly anthropometry and stool pathogen analysis, as well as extensive demographic data. This provides an opportunity to follow up on these children to assess for potential links between early life challenges (both enteric disease, infections and nutritional deficiencies) and later chronic disease risk, including lipid abnormalities, glucose intolerance and blood pressure elevations. The current proposal is to follow up on these children at the age of typical entry into puberty, as this is a common shift in metabolism when many children begin to exhibit metabolic abnormalities. We will assess these children for multiple measures:
- Anthropometry (height, weight, BMI, waist circumference)
- Assessment of pubertal stage by exam or questionnaire
- Blood pressure
- Lipids (LDL, HDL, triglycerides)
- CRP
- Oral glucose tolerance test (OGTT)
- Fasting insulin
- Metabolic syndrome (MetS) severity score
- Blood saved for future epigenetic testing
We will use linear and and logistic regression to determine associations between 1) mean number of monthly pathogens (individual pathogens and in aggregate) and 2) reported symptoms (fever, cough, diarrhea), with multiple MetS-related outcomes: BMI percentile, WC, fasting insulin, 2-hour glucose following OGTT, triglycerides, HDL cholesterol, normalized BP and a MetS diagnosis.
The underlying hypothesis is that there will be consistent links between features of MetS (in particular blood pressure, waist circumference and insulin resistance) with 1) enteric pathogen burden (overall and for particularly virulent pathogens such as Enterotoxigenic E.coli) and 2) poor early life growth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAL-ED cohort | – | –Children initially followed from birth through 2 years old in the MAL-ED study (with some additional assessments in follow-up studies since then). |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- This is a follow-up study of children who were originally in the MAL-ED cohort.
Key inclusion criteria (1 listed)
- Participated in original MAL-ED cohort
Key exclusion criteria (1 listed)
- Did not participate in original MAL-ED cohort
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
Current Systolic BP--relationship to number of enteric pathogens by age 2 years
Time frame: Measured during current study (1 year +/- 3 months)
Regression analysis of current systolic BP z-score vs. number enteric pathogens by age 2 years (from MAL-ED)
15 secondary outcomes
Current Systolic BP--relationship to BMI z-score at age 2 years
Time frame: Measured during current study (1 year +/- 3 months)
Current Diastolic BP--relationship to number of enteric pathogens by age 2 years
Time frame: Measured during current study (1 year +/- 3 months)
Current Diastolic BP--relationship to BMI z-score at age 2 years
Time frame: Measured during current study (1 year +/- 3 months)
Current BMI z-score--relationship to number of enteric pathogens by age 2 years
Time frame: Measured during current study (1 year +/- 3 months)
Current waist circumference--relationship to number of enteric pathogens by age 2 years
Time frame: Measured during current study (1 year +/- 3 months)
Metabolic syndrome (MetS) severity score--relationship to number of enteric pathogens by age 2 years
Time frame: Measured during current study (1 year +/- 3 months)
Current metabolic syndrome (MetS) severity score--relationship to BMI z-score at age 2 years
Time frame: Measured during current study (1 year +/- 3 months)
Current glucose from oral glucose tolerance test (OGTT) at 2 hours--relationship to number of enteric pathogens by age 2 years
Time frame: Measured during current study (1 year +/- 3 months)
Current glucose from oral glucose tolerance test (OGTT) at 2 hours--relationship to BMI z-score at age 2 years
Time frame: Measured during current study (1 year +/- 3 months)
Current fasting triglycerides--relationship to number of enteric pathogens by age 2 years
Time frame: Measured during current study (1 year +/- 3 months)
Current fasting triglycerides--relationship to BMI z-score at age 2 years
Time frame: Measured during current study (1 year +/- 3 months)
Current HDL cholesterol--relationship to number of enteric pathogens by age 2 years
Time frame: Measured during current study (1 year +/- 3 months)
Current HDL cholesterol--relationship to BMI z-score at age 2 years
Time frame: Measured during current study (1 year +/- 3 months)
Current fasting glucose--relationship to number of enteric pathogens by age 2 years
Time frame: Measured during current study (1 year +/- 3 months)
Current fasting glucose--relationship to BMI z-score at age 2 years
Time frame: Measured during current study (1 year +/- 3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Background: PubMed 23110643DeBoer MD, Lima AA, Oria RB, Scharf RJ, Moore SR, Luna MA, Guerrant RL. Early childhood growth failure and the developmental origins of adult disease: do enteric infections and malnutrition increase risk for the metabolic syndrome? Nutr Rev. 2012 Nov;70(11):642-53. doi: 10.1111/j.1753-4887.2012.00543.x.
- Background: PubMed 23608305DeBoer MD, Chen D, Burt DR, Ramirez-Zea M, Guerrant RL, Stein AD, Martorell R, Luna MA. Early childhood diarrhea and cardiometabolic risk factors in adulthood: the Institute of Nutrition of Central America and Panama Nutritional Supplementation Longitudinal Study. Ann Epidemiol. 2013 Jun;23(6):314-20. doi: 10.1016/j.annepidem.2013.03.012. Epub 2013 Apr 19.
- Background: PubMed 25305305Mduma ER, Gratz J, Patil C, Matson K, Dakay M, Liu S, Pascal J, McQuillin L, Mighay E, Hinken E, Ernst A, Amour C, Mvungi R, Bayyo E, Zakaria Y, Kivuyo S, Houpt ER, Svensen E. The etiology, risk factors, and interactions of enteric infections and malnutrition and the consequences for child health and development study (MAL-ED): description of the Tanzanian site. Clin Infect Dis. 2014 Nov 1;59 Suppl 4:S325-30. doi: 10.1093/cid/ciu439.
- Background: PubMed 29392824Scharf RJ, Rogawski ET, Murray-Kolb LE, Maphula A, Svensen E, Tofail F, Rasheed M, Abreu C, Vasquez AO, Shrestha R, Pendergast L, Mduma E, Koshy B, Conaway MR, Platts-Mills JA, Guerrant RL, DeBoer MD. Early childhood growth and cognitive outcomes: Findings from the MAL-ED study. Matern Child Nutr. 2018 Jul;14(3):e12584. doi: 10.1111/mcn.12584. Epub 2018 Feb 2.
- Derived from this study: PubMed 40840991Nemati K, Michael YZ, Hhando BP, Jatosh S, Houpt ER, Mduma E, DeBoer MD. Catch-up growth following early-life stunting in a low-resource area in rural Tanzania: the MAL-ED Metabolic study. BMJ Open. 2025 Aug 21;15(8):e100955. doi: 10.1136/bmjopen-2025-100955.
- Individual participant dataSharing planned: No
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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.
Mark D DeBoer, MD principal investigator
University of Virginia
Estomih Mduma, MPH study director
Haydom Global Health Research Centre
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Failure and Intestinal Infection, run by University of Virginia.
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 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: opening soon, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark D DeBoer, MD (14349245956, deboer@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Current Systolic BP--relationship to number of enteric pathogens by age 2 years (time frame: Measured during current study (1 year +/- 3 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 NCT05121935, which also lists 5 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 16 Nov 2021.