HypertensionSHSLNCT02915315
Salt-sensitive Hypertension Study in Lantian County
An observational study of Hypertension, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
Essential hypertension is a complex trait which results from interaction between environmental factors and genetic factors. Our study aimed to detect the differential expression of LncRNAs and epigenetic changes such as DNA methylation associated with salt sensitive hypertension in human based on a chronic salt… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- salt
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2017to Mar 2017
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is ready to recruit from Shaanxi Lantian County, aged 18-65 years old and sex is not limited. The exclusion criteria were hypertension, use of antihypertensive medication, clinical cardiovascular disease, chronic liver disease, chronic kidney disease, or diabetes mellitus, pregnancy, or high alcohol consumption.
Who may be able to join
- Han individuals in rural northern China
- adults aged 18-65 years
- individuals who had a mean systolic BP (SBP) between 130-160 mmHg and/or a diastolic BP (DBP) between 85-100 mmHg and no use of antihypertensive medications were identified as the proband
- the probands'parents,siblings, spouses, and offspring were recruited for the study.
Who cannot join
- Secondary hypertension
- a history of severe cardiovascular disease
- chronic kidney disease or liver disease
- unable to complete the examination
- unable/refuse to sign the informed consent form
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Genetics Study of Salt-Sensitive Hypertension in a Chinese Population
Essential hypertension is a complex trait which results from interaction between environmental factors and genetic factors. Our study aimed to detect the differential expression of LncRNAs and epigenetic changes such as DNA methylation associated with salt sensitive hypertension in human based on a chronic salt loading study conducted in Lantian county, China. Firstly, a chronic salt loading study will be conducted in a Chinese population to differentiate salt-sensitive and salt-resistant individuals. Second, LncRNAs and DNA methylation Chip analysis will be performed using samples collected from salt-sensitive and salt resistant individual, and the results will be analyzed by modern bioinformatics methods to seek for differential genetic markers. In addition, the investigators also try to examine the effects of chronic salt loading on BP, ambulatory BP, microalbuminuria and baPWV and other biochemical indexes. This project had great significance to reveal molecular genetics mechanism in the development of salt, salt-sensitive and hypertension.
Read the detailed description
The main contents include: (1) Questionnaire design: questionnaire is designed according to the research contents and purposes. The standard questionnaires will be used to collect the general information, dietary habits, lifestyle, medical history and family history etc.(2)Anthropometric measurements: blood pressure, height, body weight, waist and hip, pulse will be acquired by medical practitioners who received professional trainings based on World Health Organization (WHO) standards, and passed relevant examinations.(3) Dietary intervention: The dietary intervention comprise a 3-day baseline observation period, a low-salt diet for 7 days (3g of salt or 51.3mmol of sodium per day) and a high-salt diet for 7 days (18g of salt or 307.8mmol of sodium per day). During the baseline period, each subject is given detailed dietary instructions to avoid table salt, cooking salt, and high-salt foods for the 21-day study duration. To ensure compliance of study participants with the intervention program, they are required to have their breakfast, lunch, and dinner at the study kitchen under supervision of the study staff during the entire study period. All foods are cooked without salt. Onsite study staff members add prepackaged salt to the meals of individual subjects as indicated by the study protocol. (4) Blood and urine samples collection: morning fasting blood, nocturnal enuresis, and 24-hour urine specimen will be collected by medical staffs, and blind tubes will be set up according to 5% of the total samples. Blood biochemistries including serum total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, fasting glucose, creatinine and hsCRP can be measured using automatic biochemical analyzer. The sodium and potassium concentrations in the urine will be measured by flame photometry. The total sodium and potassium excretions in urine in 24h were calculated by multiplying the concentration and 24-h volume of urine. (5) DNA methylation and LncRNA detection: Using a method of modifying a hydrogen sulfite salt and gene chip technology to detect DNA methylation and LncRNA. (6) LncRNA: LncRNA will be measured with gene chip technology after the high salt intervention period. (7) Auxiliary examinations: Auxiliary examinations including carotid intima-media thickness, endothelium-dependent vasodilation (FMD), measurements of brachial-ankle pulse wave velocity (baPWV) and electrocardiographic parameters. The measurement will be done in hospitals by medical practitioners who received professional trainings and passed relevant examinations. (8) Data processing and statistics: the investigators should input the data to the database, and utilize software such as SPSS, STATA, Haploview and FBAT to analyze. (9)Quality control: ① Questionnaire is strictly designed and amended by epidemiologist and clinical experts. ② A standardized "Investigator Handbook" will be stipulated according to the guidelines. ③ Staff members are required to do a rigorous training and pass the exam. ④ The investigation process will be strictly supervised by the principal investigator. ⑤ Data entry use the parallel double entry method. ⑥ During laboratory testing, blank control and blind detection are applied to ensure the quality. ⑦Data analysis is performed by 2-3 postgraduates, inconsistent data need to be double checked.
- Conditions
- Hypertension
- Being tested
- salt
- Keywords
- blood pressure, Hypertrophy, Left Ventricular, arterial Stiffness, Proteinuria, baPWV, ambulatory Blood Pressure
- Medical subject headings
- Hypertension, Hypertrophy, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saltDietary supplement
Also called Sodium Chloride
The protocol comprise a questionnaire survey and physical examination during a 3-day baseline observation period, a low-salt diet for 7 days (3g of salt per day) and a high-salt diet for 7 days (18g of salt per day). During the baseline period, each subject is given detailed dietary instructions to avoid table salt, cooking salt, and high-salt foods for the 17-day study duration. To ensure compliance of study participants with the intervention program, they are required to have their breakfast, lunch, and dinner at the study kitchen under supervision of the study staff during the entire study period. All foods are cooked without salt. Onsite study staff members add repackaged salt to the meals of individual subjects as indicated by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Baseline survey period | All subjects will continue a normal diet for 3 days in which questionnaire design and anthropometric measurements will be implemented. | |
| Low-salt diet | All subjects will be instructed to maintain a low-salt diet for 7 days (3g of salt or 51.3mmol of sodium per day). Receives: Dietary Supplement: salt | |
| High -salt diet | After washout period, all subjects will be instructed to maintain a 18g of salt or 307.8mmol of sodium per day. Receives: Dietary Supplement: salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure value(mmHg)
The study will last approximately 3 months (Oct 2016 to Dec 2016). During this period, each subject will receive a three-day baseline survey examination. Three BPs (mmHg) measurement will be obtained using a Blood Pressure Monitor on the first day of the three-day baseline survey period.
Measured: The first day of the three-day baseline survey period.
Secondary outcomes (5)
Ambulatory Blood Pressure Monitoring（mmHg）
The study will last approximately 3 months (Oct 2016 to Dec 2016). During this period, each subject will receive a three-day baseline survey examination. Ambulatory blood pressure（mmHg）will be measured with Omron Ambulatory Blood Pressure Monitor during the three-day baseline survey period
Measured: Second day of the three-day baseline survey period
Microalbuminuria（mg/24h）
The study will last approximately 3 months (Oct 2016 to Dec 2016). During this period, each subject will receive a three-day baseline survey examination. On the second day, 24-hour urinary will be collected and the concentrations of microalbuminuria in the urine sample will be measured with Hitachi biochemical analyzer. The 24-h microalbuminuria（mg/24h）of each subject is calculated as the concentration of microalbuminuria multiplied by the 24-h urine volume of each individual.
Measured: Second day of the three-day baseline survey period
Increased arterial stiffness（baPWV,mm/s）
The study will last approximately 3 months (Oct 2016 to Dec 2016). During this period, each subject will receive a three-day baseline survey examination. Brachial-ankle pulse wave velocity（baPWV, mm/s）will be measured with Noninvasive automatic waveform analyzer during the three-day baseline survey period.
Measured: Second day of the three-day baseline survey period
DNA methylation
The study will last approximately 3 months (Oct 2016 to Dec 2016). During this period, each subject will receive a seven-day high salt intervention subsequent to a seven-day low salt intervention. DNA methylation will be measured with a method of modifying a hydrogen sulfite salt at the last day of the low salt or high salt intervention.
Measured: Last day of the low salt or high salt intervention period
LncRNA
The study will last approximately 3 months (Oct 2016 to Dec 2016). During this period, each subject will receive a seven-day high salt intervention subsequent to a seven-day low salt intervention. IncRNA will be measured with gene chip technology at the last day of the low salt or high salt intervention.
Measured: Last day of the low salt or high salt intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study start28 Feb 2017 (estimated)
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (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 HypertensionStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianjun Mu, doctor, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915315
- Sponsor's protocol ID
- NSFC(81570381)
- Acronym
- SHSL
- Status last verified
- Sep 2016
- First submitted
- 21 Sep 2016
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mu J, Zheng S, Lian Q, Liu F, Liu Z. Evolution of blood pressure from adolescents to youth in salt sensitivies: a 18-year follow-up study in Hanzhong children cohort. Nutr J. 2012 Sep 14;11:70. doi: 10.1186/1475-2891-11-70.
PubMed 22978814Liu F, Zheng S, Mu J, Chu C, Wang L, Wang Y, Xiao H, Wang D, Cao Y, Ren K, Liu E, Yuan Z. Common variation in with no-lysine kinase 1 (WNK1) and blood pressure responses to dietary sodium or potassium interventions- family-based association study. Circ J. 2013;77(1):169-74. doi: 10.1253/circj.cj-12-0900. Epub 2012 Oct 12.
PubMed 23059770Wang Y, Liu FQ, Wang D, Mu JJ, Ren KY, Guo TS, Chu C, Wang L, Geng LK, Yuan ZY. Effect of salt intake and potassium supplementation on serum renalase levels in Chinese adults: a randomized trial. Medicine (Baltimore). 2014 Jul;93(6):e44. doi: 10.1097/MD.0000000000000044.
PubMed 25058146Wang Y, Jia H, Gao WH, Zou T, Yao S, Du MF, Zhang XY, Chu C, Liao YY, Chen C, Wang D, Ma Q, Hu JW, Wang KK, Yan Y, Sun Y, Hu GL, Niu ZJ, Zhou HW, Zhang X, Wang X, Li CH, Chen FY, Gao K, Zhang J, Guan YJ, Chang J, Yang TL, Mu JJ. Associations of plasma PAPP-A2 and genetic variations with salt sensitivity, blood pressure changes and hypertension incidence in Chinese adults. J Hypertens. 2021 Sep 1;39(9):1817-1825. doi: 10.1097/HJH.0000000000002846.
PubMed 33783375Zhang J, Yin Y, Chen L, Chu C, Wang Y, Lv Y, He M, Martin M, Huang PH, Mu JJ, Shyy JY, Yuan ZY. Short-Term High-Salt Diet Increases Corin Level to Regulate the Salt-Water Balance in Humans and Rodents. Am J Hypertens. 2018 Jan 12;31(2):253-260. doi: 10.1093/ajh/hpx148.
PubMed 28985241
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics Study of Salt-Sensitive Hypertension in a Chinese Population
- ClinicalTrials.gov ID
- NCT02915315
- Acronym / sponsor ID
- SHSL / NSFC(81570381)
- Conditions
- Hypertension
- Keywords
- blood pressure, Hypertrophy, Left Ventricular, arterial Stiffness, Proteinuria, baPWV, ambulatory Blood Pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 28 Feb 2017 (estimated)
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 27 Sep 2016 (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.
Essential hypertension is a complex trait which results from interaction between environmental factors and genetic factors. Our study aimed to detect the differential expression of LncRNAs and epigenetic changes such as DNA methylation associated with salt sensitive hypertension in human based on a chronic salt loading study conducted in Lantian county, China. Firstly, a chronic salt loading study will be conducted in a Chinese population to differentiate salt-sensitive and salt-resistant individuals. Second, LncRNAs and DNA methylation Chip analysis will be performed using samples collected from salt-sensitive and salt resistant individual, and the results will be analyzed by modern bioinformatics methods to seek for differential genetic markers. In addition, the investigators also try to examine the effects of chronic salt loading on BP, ambulatory BP, microalbuminuria and baPWV and other biochemical indexes. This project had great significance to reveal molecular genetics mechanism in the development of salt, salt-sensitive and hypertension.
Detailed description
The main contents include: (1) Questionnaire design: questionnaire is designed according to the research contents and purposes. The standard questionnaires will be used to collect the general information, dietary habits, lifestyle, medical history and family history etc.(2)Anthropometric measurements: blood pressure, height, body weight, waist and hip, pulse will be acquired by medical practitioners who received professional trainings based on World Health Organization (WHO) standards, and passed relevant examinations.(3) Dietary intervention: The dietary intervention comprise a 3-day baseline observation period, a low-salt diet for 7 days (3g of salt or 51.3mmol of sodium per day) and a high-salt diet for 7 days (18g of salt or 307.8mmol of sodium per day). During the baseline period, each subject is given detailed dietary instructions to avoid table salt, cooking salt, and high-salt foods for the 21-day study duration. To ensure compliance of study participants with the intervention program, they are required to have their breakfast, lunch, and dinner at the study kitchen under supervision of the study staff during the entire study period. All foods are cooked without salt. Onsite study staff members add prepackaged salt to the meals of individual subjects as indicated by the study protocol. (4) Blood and urine samples collection: morning fasting blood, nocturnal enuresis, and 24-hour urine specimen will be collected by medical staffs, and blind tubes will be set up according to 5% of the total samples. Blood biochemistries including serum total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, fasting glucose, creatinine and hsCRP can be measured using automatic biochemical analyzer. The sodium and potassium concentrations in the urine will be measured by flame photometry. The total sodium and potassium excretions in urine in 24h were calculated by multiplying the concentration and 24-h volume of urine. (5) DNA methylation and LncRNA detection: Using a method of modifying a hydrogen sulfite salt and gene chip technology to detect DNA methylation and LncRNA. (6) LncRNA: LncRNA will be measured with gene chip technology after the high salt intervention period. (7) Auxiliary examinations: Auxiliary examinations including carotid intima-media thickness, endothelium-dependent vasodilation (FMD), measurements of brachial-ankle pulse wave velocity (baPWV) and electrocardiographic parameters. The measurement will be done in hospitals by medical practitioners who received professional trainings and passed relevant examinations. (8) Data processing and statistics: the investigators should input the data to the database, and utilize software such as SPSS, STATA, Haploview and FBAT to analyze. (9)Quality control: ① Questionnaire is strictly designed and amended by epidemiologist and clinical experts. ② A standardized "Investigator Handbook" will be stipulated according to the guidelines. ③ Staff members are required to do a rigorous training and pass the exam. ④ The investigation process will be strictly supervised by the principal investigator. ⑤ Data entry use the parallel double entry method. ⑥ During laboratory testing, blank control and blind detection are applied to ensure the quality. ⑦Data analysis is performed by 2-3 postgraduates, inconsistent data need to be double checked.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baseline survey period | – | –All subjects will continue a normal diet for 3 days in which questionnaire design and anthropometric measurements will be implemented. |
| Low-salt diet | – | Dietary Supplement: saltAll subjects will be instructed to maintain a low-salt diet for 7 days (3g of salt or 51.3mmol of sodium per day). |
| High -salt diet | – | Dietary Supplement: saltAfter washout period, all subjects will be instructed to maintain a 18g of salt or 307.8mmol of sodium per day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is ready to recruit from Shaanxi Lantian County, aged 18-65 years old and sex is not limited. The exclusion criteria were hypertension, use of antihypertensive medication, clinical cardiovascular disease, chronic liver disease, chronic kidney disease, or diabetes mellitus, pregnancy, or high alcohol consumption.
Key inclusion criteria (4 listed)
- Han individuals in rural northern China
- adults aged 18-65 years
- individuals who had a mean systolic BP (SBP) between 130-160 mmHg and/or a diastolic BP (DBP) between 85-100 mmHg and no use of antihypertensive medications were identified as the proband
- the probands'parents,siblings, spouses, and offspring were recruited for the study.
Key exclusion criteria (5 listed)
- Secondary hypertension
- a history of severe cardiovascular disease
- chronic kidney disease or liver disease
- unable to complete the examination
- unable/refuse to sign the informed consent form
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 |
|---|---|---|
| saltAlso: Sodium ChlorideThe protocol comprise a questionnaire survey and physical examination during a 3-day baseline observation period, a low-salt diet for 7 days (3g of salt per day) and a high-salt diet for 7 days (18g of salt per day). During the baseline period, each subject is given detailed dietary instructions to avoid table salt, cooking salt, and high-salt foods for the 17-day study duration. To ensure compliance of study participants with the intervention program, they are required to have their breakfast, lunch, and dinner at the study kitchen under supervision of the study staff during the entire study period. All foods are cooked without salt. Onsite study staff members add repackaged salt to the meals of individual subjects as indicated by the study protocol. | Dietary supplement | High -salt diet, Low-salt diet |
Primary outcome
blood pressure value(mmHg)
Time frame: The first day of the three-day baseline survey period.
The study will last approximately 3 months (Oct 2016 to Dec 2016). During this period, each subject will receive a three-day baseline survey examination. Three BPs (mmHg) measurement will be obtained using a Blood Pressure Monitor on the first day of the three-day baseline survey period.
5 secondary outcomes
Ambulatory Blood Pressure Monitoring（mmHg）
Time frame: Second day of the three-day baseline survey period
Microalbuminuria（mg/24h）
Time frame: Second day of the three-day baseline survey period
Increased arterial stiffness（baPWV,mm/s）
Time frame: Second day of the three-day baseline survey period
DNA methylation
Time frame: Last day of the low salt or high salt intervention period
LncRNA
Time frame: Last day of the low salt or high salt intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Results publication: PubMed 22978814Mu J, Zheng S, Lian Q, Liu F, Liu Z. Evolution of blood pressure from adolescents to youth in salt sensitivies: a 18-year follow-up study in Hanzhong children cohort. Nutr J. 2012 Sep 14;11:70. doi: 10.1186/1475-2891-11-70.
- Results publication: PubMed 23059770Liu F, Zheng S, Mu J, Chu C, Wang L, Wang Y, Xiao H, Wang D, Cao Y, Ren K, Liu E, Yuan Z. Common variation in with no-lysine kinase 1 (WNK1) and blood pressure responses to dietary sodium or potassium interventions- family-based association study. Circ J. 2013;77(1):169-74. doi: 10.1253/circj.cj-12-0900. Epub 2012 Oct 12.
- Results publication: PubMed 25058146Wang Y, Liu FQ, Wang D, Mu JJ, Ren KY, Guo TS, Chu C, Wang L, Geng LK, Yuan ZY. Effect of salt intake and potassium supplementation on serum renalase levels in Chinese adults: a randomized trial. Medicine (Baltimore). 2014 Jul;93(6):e44. doi: 10.1097/MD.0000000000000044.
- Derived from this study: PubMed 33783375Wang Y, Jia H, Gao WH, Zou T, Yao S, Du MF, Zhang XY, Chu C, Liao YY, Chen C, Wang D, Ma Q, Hu JW, Wang KK, Yan Y, Sun Y, Hu GL, Niu ZJ, Zhou HW, Zhang X, Wang X, Li CH, Chen FY, Gao K, Zhang J, Guan YJ, Chang J, Yang TL, Mu JJ. Associations of plasma PAPP-A2 and genetic variations with salt sensitivity, blood pressure changes and hypertension incidence in Chinese adults. J Hypertens. 2021 Sep 1;39(9):1817-1825. doi: 10.1097/HJH.0000000000002846.
- Derived from this study: PubMed 28985241Zhang J, Yin Y, Chen L, Chu C, Wang Y, Lv Y, He M, Martin M, Huang PH, Mu JJ, Shyy JY, Yuan ZY. Short-Term High-Salt Diet Increases Corin Level to Regulate the Salt-Water Balance in Humans and Rodents. Am J Hypertens. 2018 Jan 12;31(2):253-260. doi: 10.1093/ajh/hpx148.
- 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. This study is not recruiting at the moment.
Jianjun Mu, doctor principal investigator
First Affiliated Hospital Xi'an Jiaotong University
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by First Affiliated Hospital Xi'an Jiaotong University.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Feb 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianjun Mu, doctor (0086-029-85323804, mujjun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure value(mmHg) (time frame: The first day of the three-day baseline survey period.). 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 NCT02915315, 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 27 Feb 2017.