StrokeSSaSSNCT02092090
China Salt Substitute and Stroke Study
A study testing Dietary sodium reduction in people with Stroke, run by The George Institute at 5 sites in China.
Trial summary
The study is a large scale cluster randomised trial to evaluate the effects of sodium reduction based upon the use of salt substitute on the risk of stroke defined as the occurrence of stroke and stroke deaths. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Dietary sodium reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,996 participants
- Where
- 5 sitesChina
- Study dates
- 9 Jul 2014to 4 Sep 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Disease history
- Prior stroke and/or
- Aged 60 years or over and with uncontrolled high blood pressure (systolic blood pressure >=140 millimeters of mercury (mmHg) at visit if on blood pressure lowering medication; systolic blood pressure>=160 millimeters of mercury (mmHg) if not on blood pressure lowering medication)
- Ownership of a phone by the participant or a household member
Who cannot join
- Participant or family member is using a potassium-sparing diuretic
- Participant or family member is using a potassium supplement
- Participant or family member has serious renal impairment
- Participant or family member has other reason for concern about use of salt substitute
- Participant eats most meals outside the home
- Participant is not expected to live longer than 6 months from the date of assessment as estimated by the village doctor
- Another family member living in the same household has already been included in the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Changzhi Medical Colledge
Changzhi, Shanxi, 046000
China Medical Universtity
Shenyang, Liaoning, 110001
Hebei Province Centre for Disease Control and Prevention
Shijiazhuang, Hebei, 71000
Xi'an Jiaotong University
Xi'an, Shaanxi, 710049
Ningxia Medical University
Yinchuan, Ningxia, 750004
About this study
Official title: A LARGE-SCALE CLUSTER RANDOMIZED TRIAL TO DETERMINE THE EFFECTS OF SODIUM REDUCTION ON STROKE: THE CHINA SALT SUBSTITUTE AND STROKE STUDY (SSaSS)
The study is a large scale cluster randomised trial to evaluate the effects of sodium reduction based upon the use of salt substitute on the risk of stroke defined as the occurrence of stroke and stroke deaths. The corresponding null hypothesis that will be tested is that sodium reduction will have no effect upon stroke risk. The secondary objectives are to determine effects of sodium reduction on major vascular events and total mortality.
Read the detailed description
Lowering sodium intake and the use of salt substitute have been proved to lower blood pressure levels. Effects on the risks of vascular outcomes have not been defined in an adequately powered randomised trial. Rural Chinese are known to consume very large quantities of sodium and to suffer from very high rates of hypertension and stroke. This study is a large scale cluster randomised trial done in rural areas of China. The study will define the effects of a salt substitute-based sodium reduction strategy on the primary outcome of stroke. Secondary endpoints will include major cardiovascular events and total mortality. The study will be conducted in 600 rural villages across five Northern Chinese provinces and Tibet. The study will recruit 35 individuals at elevated risk of stroke from each village for a total of 21,000 participants. The participating villages will be randomised into intervention and control group with 1:1 allocation. Recruitment will prioritise individuals with a history of stroke but also include older individuals with high blood pressure. Follow up is scheduled for 5 years. Individuals in intervention villages will receive repeated dietary advice and a supply of low sodium salt substitute while individuals in control villages will receive dietary advice at baseline only. Every 6 months throughout follow-up each individual will be contacted by phone call to inquire about the occurrence of stroke, hospitalisation for any cause and diagnoses of any other serious illnesses. The interview will be structured and done by individuals masked to the randomised assignment of each individual. For all deaths identified and all events that might possibly be non-fatal strokes a home visit will be made. A series of process indicators including urinary sodium, urinary potassium, blood pressure, knowledge about sodium and use of salt substitute will also be measured on a random sample of at least 20 individuals drawn from a random selection of 60 villages at baseline and every year thereafter.
- Conditions
- Stroke
- Being tested
- Dietary sodium reduction
- Keywords
- salt substitute, sodium reduction, stroke, cluster randomized trial, China
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary sodium reductionBehavioural
Also called Reduced-sodium added-potassium salt substitute
Ongoing dietary advice and a supply of a reduced-sodium added-potassium salt substitute
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Dietary advice at baseline only |
| Dietary sodium reduction | Experimental | Dietary advice and reduced-sodium added-potassium salt substitute Receives: Behavioral: Dietary sodium reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke
The primary outcome will be stroke defined according to standard criteria on the basis of an acute disturbance of focal neurological function and resulting in death or symptoms lasting more than 24 hours. Imaging, clinical and laboratory data will be collected wherever possible.
Measured: 5 years
Secondary outcomes (2)
Total major vascular events
The composite of stroke, acute coronary syndrome or vascular death
Measured: 5 years
Total mortality
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study start9 Jul 2014
- Primary completion4 Sep 2020
- Study completion4 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20,996 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University, Northwestern University, Imperial College London, China Medical University, China, Changzhi Medical College, Centers for Disease Control and Prevention, China, Ningxia Medical University, Xi'an Jiaotong University
- Responsible party
- Sponsor
- Investigators
- Bruce C Neal, PhD, Principal investigator, The George Institute for Global Health, AustraliaYangfeng Wu, PhD, Principal investigator, The George Institute for Global Health at Peking University Health Science CentreDarwin Labarthe, PhD, Principal investigator, Northwestern UniversityPaul Elliott, PhD, Principal investigator, School of Public Health, Imperial College LondonLijing L Yan, PhD, Principal investigator, The George Institute for Global Health at Peking University Health Science CentreNicole Y Li, PhD, Principal investigator, The George Institute for Global Health, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092090
- Sponsor's protocol ID
- SSaSS
- Other IDs
- Grant ID 1049417
- Acronym
- SSaSS
- Status last verified
- Apr 2021
- First submitted
- 12 Mar 2014
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang X, Yin X, Yap ML, Li Q, Huang L, Liu Y, Zhou B, Li Z, Zhao Y, Sun J, Yu Y, Yan LL, Wu Y, Neal B, Tian M. Effect of sodium-reduced potassium-enriched salt substitutes on stomach cancer: the Salt Substitute and Stroke Study (SSaSS). BMC Med. 2025 Apr 23;23(1):236. doi: 10.1186/s12916-025-04068-0.
PubMed 40264179Ding X, Zhang X, Huang L, Xiong S, Li Z, Zhao Y, Zhou B, Yin X, Xu B, Wu Y, Neal B, Tian M, Yan LL. Salt Substitution and Recurrent Stroke and Death: A Randomized Clinical Trial. JAMA Cardiol. 2025 Apr 1;10(4):343-350. doi: 10.1001/jamacardio.2024.5417.
PubMed 39908026Wang F, Pi Y, Zhao Y, Zhang Y, Zhou B, Li Z, Sun J, Yu Y, Tian M, Yang M, Huang L, Song H, Neal B, Kissock KR. Effect of salt substitution on fracture-a secondary analysis of the Salt Substitute and Stroke Study (SSaSS). BMC Med. 2024 Sep 4;22(1):366. doi: 10.1186/s12916-024-03586-7.
PubMed 39232779Qi Z, Tang S, Hao Y, Li Y, Hao T, Yang H, Shen Y, Huang L, Tian M, Feng X, Li Z. Effect of salt substitute and antihypertensive medications among high cardiovascular risk patients: A sub-study of Salt Substitute and Stroke Study (SSaSS). J Clin Hypertens (Greenwich). 2024 Sep;26(9):1063-1072. doi: 10.1111/jch.14872. Epub 2024 Jul 16.
PubMed 39012269Yu J, Arnott C, Li Q, Di Tanna GL, Tian M, Huang L, Yin X, Zhang X, Pearson SA, Labarthe DR, Elliott P, Yan LL, Zhou B, Wu Y, Neal B. Secondary Analysis of the Salt Substitute and Stroke Study (SSaSS): Effects of Potassium-Enriched Salt on Cardiac Outcomes. Hypertension. 2024 May;81(5):1031-1040. doi: 10.1161/HYPERTENSIONAHA.123.22410. Epub 2024 Mar 11.
PubMed 38465623Haghdoost F, Gnanenthiran SR, Shan S, Kaistha P, Huang L, Tian M, Liu Y, Yin X, Zhang X, Hao Z, Wu Y, Di Tanna GL, Neal B, Rodgers A. The effect of salt substitution on frequency and severity of headache: results from the SSaSS cluster-randomised controlled trial of 20,995 participants. Eur J Clin Nutr. 2024 May;78(5):401-406. doi: 10.1038/s41430-024-01419-7. Epub 2024 Feb 24.
PubMed 38402353Yin X, Paige E, Tian M, Li Q, Huang L, Yu J, Rodgers A, Elliott P, Wu Y, Neal B. The Proportion of Dietary Salt Replaced With Potassium-Enriched Salt in the SSaSS: Implications for Scale-Up. Hypertension. 2023 May;80(5):956-965. doi: 10.1161/HYPERTENSIONAHA.122.20115. Epub 2023 Jan 11.
PubMed 36628969Neal B, Wu Y, Feng X, Zhang R, Zhang Y, Shi J, Zhang J, Tian M, Huang L, Li Z, Yu Y, Zhao Y, Zhou B, Sun J, Liu Y, Yin X, Hao Z, Yu J, Li KC, Zhang X, Duan P, Wang F, Ma B, Shi W, Di Tanna GL, Stepien S, Shan S, Pearson SA, Li N, Yan LL, Labarthe D, Elliott P. Effect of Salt Substitution on Cardiovascular Events and Death. N Engl J Med. 2021 Sep 16;385(12):1067-1077. doi: 10.1056/NEJMoa2105675. Epub 2021 Aug 29.
PubMed 34459569Li KC, Tian M, Neal B, Huang L, Yu J, Liu Y, Yin X, Zhang X, Wu Y, Li N, Elliott P, Yan L, Labarthe D, Hao Z, Shi J, Feng X, Zhang J, Zhang Y, Zhang R, Zhou B, Li Z, Sun J, Zhao Y, Yu Y, Si L, Lung T. Protocol for the economic evaluation of the China Salt Substitute and Stroke Study (SSaSS). BMJ Open. 2021 Jul 20;11(7):e045929. doi: 10.1136/bmjopen-2020-045929.
PubMed 34285006
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A LARGE-SCALE CLUSTER RANDOMIZED TRIAL TO DETERMINE THE EFFECTS OF SODIUM REDUCTION ON STROKE: THE CHINA SALT SUBSTITUTE AND STROKE STUDY (SSaSS)
- ClinicalTrials.gov ID
- NCT02092090
- Acronym / sponsor ID
- SSaSS / SSaSS
- Conditions
- Stroke
- Keywords
- salt substitute, sodium reduction, stroke, cluster randomized trial, China
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,996 participants (actual)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- Peking University, Northwestern University, Imperial College London, China Medical University, China, Changzhi Medical College, Centers for Disease Control and Prevention, China, Ningxia Medical University, Xi'an Jiaotong University
- Study start
- 9 Jul 2014 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 19 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a large scale cluster randomised trial to evaluate the effects of sodium reduction based upon the use of salt substitute on the risk of stroke defined as the occurrence of stroke and stroke deaths. The corresponding null hypothesis that will be tested is that sodium reduction will have no effect upon stroke risk. The secondary objectives are to determine effects of sodium reduction on major vascular events and total mortality.
Detailed description
Lowering sodium intake and the use of salt substitute have been proved to lower blood pressure levels. Effects on the risks of vascular outcomes have not been defined in an adequately powered randomised trial. Rural Chinese are known to consume very large quantities of sodium and to suffer from very high rates of hypertension and stroke. This study is a large scale cluster randomised trial done in rural areas of China. The study will define the effects of a salt substitute-based sodium reduction strategy on the primary outcome of stroke. Secondary endpoints will include major cardiovascular events and total mortality. The study will be conducted in 600 rural villages across five Northern Chinese provinces and Tibet. The study will recruit 35 individuals at elevated risk of stroke from each village for a total of 21,000 participants. The participating villages will be randomised into intervention and control group with 1:1 allocation. Recruitment will prioritise individuals with a history of stroke but also include older individuals with high blood pressure. Follow up is scheduled for 5 years. Individuals in intervention villages will receive repeated dietary advice and a supply of low sodium salt substitute while individuals in control villages will receive dietary advice at baseline only. Every 6 months throughout follow-up each individual will be contacted by phone call to inquire about the occurrence of stroke, hospitalisation for any cause and diagnoses of any other serious illnesses. The interview will be structured and done by individuals masked to the randomised assignment of each individual. For all deaths identified and all events that might possibly be non-fatal strokes a home visit will be made. A series of process indicators including urinary sodium, urinary potassium, blood pressure, knowledge about sodium and use of salt substitute will also be measured on a random sample of at least 20 individuals drawn from a random selection of 60 villages at baseline and every year thereafter.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Dietary advice at baseline only |
| Dietary sodium reduction | Experimental | Behavioral: Dietary sodium reductionDietary advice and reduced-sodium added-potassium salt substitute |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Disease history
- Prior stroke and/or
- Aged 60 years or over and with uncontrolled high blood pressure (systolic blood pressure >=140 millimeters of mercury (mmHg) at visit if on blood pressure lowering medication; systolic blood pressure>=160 millimeters of mercury (mmHg) if not on blood pressure lowering medication)
- Ownership of a phone by the participant or a household member
Key exclusion criteria (7 listed)
- Participant or family member is using a potassium-sparing diuretic
- Participant or family member is using a potassium supplement
- Participant or family member has serious renal impairment
- Participant or family member has other reason for concern about use of salt substitute
- Participant eats most meals outside the home
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 |
|---|---|---|
| Dietary sodium reductionAlso: Reduced-sodium added-potassium salt substituteOngoing dietary advice and a supply of a reduced-sodium added-potassium salt substitute | Behavioural | Dietary sodium reduction |
Primary outcome
Stroke
Time frame: 5 years
The primary outcome will be stroke defined according to standard criteria on the basis of an acute disturbance of focal neurological function and resulting in death or symptoms lasting more than 24 hours. Imaging, clinical and laboratory data will be collected wherever possible.
2 secondary outcomes
Total major vascular events
Time frame: 5 years
Total mortality
Time frame: 5 years
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 8 Apr 2021.
- Derived from this study: PubMed 40264179Zhang X, Yin X, Yap ML, Li Q, Huang L, Liu Y, Zhou B, Li Z, Zhao Y, Sun J, Yu Y, Yan LL, Wu Y, Neal B, Tian M. Effect of sodium-reduced potassium-enriched salt substitutes on stomach cancer: the Salt Substitute and Stroke Study (SSaSS). BMC Med. 2025 Apr 23;23(1):236. doi: 10.1186/s12916-025-04068-0.
- Derived from this study: PubMed 39908026Ding X, Zhang X, Huang L, Xiong S, Li Z, Zhao Y, Zhou B, Yin X, Xu B, Wu Y, Neal B, Tian M, Yan LL. Salt Substitution and Recurrent Stroke and Death: A Randomized Clinical Trial. JAMA Cardiol. 2025 Apr 1;10(4):343-350. doi: 10.1001/jamacardio.2024.5417.
- Derived from this study: PubMed 39232779Wang F, Pi Y, Zhao Y, Zhang Y, Zhou B, Li Z, Sun J, Yu Y, Tian M, Yang M, Huang L, Song H, Neal B, Kissock KR. Effect of salt substitution on fracture-a secondary analysis of the Salt Substitute and Stroke Study (SSaSS). BMC Med. 2024 Sep 4;22(1):366. doi: 10.1186/s12916-024-03586-7.
- Derived from this study: PubMed 39012269Qi Z, Tang S, Hao Y, Li Y, Hao T, Yang H, Shen Y, Huang L, Tian M, Feng X, Li Z. Effect of salt substitute and antihypertensive medications among high cardiovascular risk patients: A sub-study of Salt Substitute and Stroke Study (SSaSS). J Clin Hypertens (Greenwich). 2024 Sep;26(9):1063-1072. doi: 10.1111/jch.14872. Epub 2024 Jul 16.
- Derived from this study: PubMed 38465623Yu J, Arnott C, Li Q, Di Tanna GL, Tian M, Huang L, Yin X, Zhang X, Pearson SA, Labarthe DR, Elliott P, Yan LL, Zhou B, Wu Y, Neal B. Secondary Analysis of the Salt Substitute and Stroke Study (SSaSS): Effects of Potassium-Enriched Salt on Cardiac Outcomes. Hypertension. 2024 May;81(5):1031-1040. doi: 10.1161/HYPERTENSIONAHA.123.22410. Epub 2024 Mar 11.
- Derived from this study: PubMed 38402353Haghdoost F, Gnanenthiran SR, Shan S, Kaistha P, Huang L, Tian M, Liu Y, Yin X, Zhang X, Hao Z, Wu Y, Di Tanna GL, Neal B, Rodgers A. The effect of salt substitution on frequency and severity of headache: results from the SSaSS cluster-randomised controlled trial of 20,995 participants. Eur J Clin Nutr. 2024 May;78(5):401-406. doi: 10.1038/s41430-024-01419-7. Epub 2024 Feb 24.
- Derived from this study: PubMed 36628969Yin X, Paige E, Tian M, Li Q, Huang L, Yu J, Rodgers A, Elliott P, Wu Y, Neal B. The Proportion of Dietary Salt Replaced With Potassium-Enriched Salt in the SSaSS: Implications for Scale-Up. Hypertension. 2023 May;80(5):956-965. doi: 10.1161/HYPERTENSIONAHA.122.20115. Epub 2023 Jan 11.
- Derived from this study: PubMed 34459569Neal B, Wu Y, Feng X, Zhang R, Zhang Y, Shi J, Zhang J, Tian M, Huang L, Li Z, Yu Y, Zhao Y, Zhou B, Sun J, Liu Y, Yin X, Hao Z, Yu J, Li KC, Zhang X, Duan P, Wang F, Ma B, Shi W, Di Tanna GL, Stepien S, Shan S, Pearson SA, Li N, Yan LL, Labarthe D, Elliott P. Effect of Salt Substitution on Cardiovascular Events and Death. N Engl J Med. 2021 Sep 16;385(12):1067-1077. doi: 10.1056/NEJMoa2105675. Epub 2021 Aug 29.
- Derived from this study: PubMed 34285006Li KC, Tian M, Neal B, Huang L, Yu J, Liu Y, Yin X, Zhang X, Wu Y, Li N, Elliott P, Yan L, Labarthe D, Hao Z, Shi J, Feng X, Zhang J, Zhang Y, Zhang R, Zhou B, Li Z, Sun J, Zhao Y, Yu Y, Si L, Lung T. Protocol for the economic evaluation of the China Salt Substitute and Stroke Study (SSaSS). BMJ Open. 2021 Jul 20;11(7):e045929. doi: 10.1136/bmjopen-2020-045929.
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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.
Bruce C Neal, PhD principal investigator
The George Institute for Global Health, Australia
Yangfeng Wu, PhD principal investigator
The George Institute for Global Health at Peking University Health Science Centre
Darwin Labarthe, PhD principal investigator
Northwestern University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary sodium reduction in people with Stroke, run by The George Institute at 5 sites in China.
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 7 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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?
Stroke (time frame: 5 years). 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 NCT02092090, which also lists 9 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 8 Apr 2021.