Blood PressureNCT02021435
Tibet Salt Reduction Study
A study testing salt substitute in people with Blood Pressure and Cardiovascular Diseases, run by Beijing Jishuitan Hospital at 2 sites in China.
Trial summary
1. Research background High blood pressure is one of the most important risk factors to cardiovascular diseases (CVDs). Reducing population blood pressure can control CVD incidence and lower mortality effectively. Much research has proven that adjusting for Na and K intake level can reduce blood pressure. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Cardiovascular Diseases, Death
- What is being tested?
- salt substitute
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,500 participants
- Where
- 2 sitesChina
- Study dates
- Apr 2014to Mar 2016
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All family households in the selected satellite village will be invited to participate in the study
- Family households will be excluded from participating if they meet one or more of the following exclusion criteria:
- Any member in the family is using a potassium-sparing diuretic
- Any member in the family is using a potassium supplement
- Any member in the family has serious renal impairment
- Any member in the family over 18 could not sign informed consent
- Life expectancy of any member in the family is shorter than 6 months in doctor's opinion
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Study site
Damxung, Tibet, 851500
Study site
Maizhokunggar, Tibet, 850200
About this study
Official title: Using Salt Substitute to Reduce Population Blood Pressure in Tibet: Tibet Salt Reduction Study
- Research background
- High blood pressure is one of the most important risk factors to cardiovascular diseases (CVDs). Reducing population blood pressure can control CVD incidence and lower mortality effectively. Much research has proven that adjusting for Na and K intake level can reduce blood pressure. According to the China Salt Substitute Study, the systolic blood pressure of intervention group which used salt substitute is 5.4 mmHg lower than that of control group. Life expectancy in Tibet is 67 years old. It is estimated that the use of salt substitute among population in Tibet can reduce total mortality in Tibet by 20%. China Salt Substitute Study in Tibet (CSSS-Tibet), found that salt substitute is effective in lowering both systolic and diastolic blood pressure and offers a simple, low-cost approach for hypertension control among Tibetans in China (unpublished results). However, the study focused on hypertensive patients, the effectiveness of hypertension control by providing free salt substitute to the entire population remains unknown, and a large-scale trial is needed.
Read more
- Objectives
- Primary objective is to observe the effect of providing salt substitute on population blood pressure in Tibet. Secondary objective is to observe the effect of such intervention on population mortality, cardiovascular mortality and life expectancy. In addition, the data collected from high-risk population (sub-group) in the study will be used in China Salt Substitute and Stroke Study (SSaSS). Also, serum cholesterol and random blood glucose of people over 60 in Tibet will be collected.
- Method
- The study is a open, cluster-randomized, controlled trial.
- 30 villages with 15 to 35 households each and a distance of at least five kilometers in between will be selected from Damxung county and Maizhokunggar county. The two counties have an average altitude of over 4000 meters in Tibet Autonomous Region.
- All selected villages will be randomly assigned to intervention group or control group on a 1:1 ratio.
- All household in the selected villages will be recruited if they meet the eligibility criteria. Approximately 4,500 participants will be enrolled
- Intervention group receives free salt substitute. Control group will continue to buy their own normal salt. Both group will receive the same health education on salt reduction.
- Outcome - Primary outcome is blood pressure. Secondary outcomes include total mortality, cardiovascular disease mortality, life expectancy, serum cholesterol level of people over 60, and random blood glucose level of people over 60.
- Conditions
- Blood Pressure, Cardiovascular Diseases, Death
- Being tested
- salt substitute
- Medical subject headings
- Cardiovascular Diseases, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salt substituteDietary supplement
Free salt substitute provided
| Study group | Role | What they receive |
|---|---|---|
| Salt Substitute | Experimental | salt substitute Receives: Dietary Supplement: salt substitute |
| Control | No intervention | Participants continue to buy salt at their own expense |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in change from baseline in blood pressure between intervention and control
Measured: Baseline, 6,12, 24 months
Secondary outcomes (5)
Difference in total mortality between intervention and control
Measured: 6, 12, 24 months
Difference in cardiovascular disease mortality between intervention and control
Measured: 6,12, 24 months
Difference in life expectancy between intervention and control group
Measured: 6, 12, 24 months
The distribution of blood glucose level in population over 60 years old
Measured: baseline
Distribution of serum cholesterol level in population over 60 years old
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startApr 2014
- Primary completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- None (open label)
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The George Institute for Global Health at PUHSC, The George Institute for Global Health, Australia, Science and Technology Department of Ningxia, People's Hospital of Tibet, People's Hospital of Maizhokunggar, Tibet University, Peking University, People's Hospital of Damxung County, Tibet
- Responsible party
- Principal investigator, Xingshan Zhao, Beijing Jishuitan Hospital
- Investigators
- Xingshan Zhao, M.D., Principal investigator, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021435
- Sponsor's protocol ID
- 2013BAI05B04
- Status last verified
- Jan 2014
- First submitted
- 20 Dec 2013
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Salt Substitute to Reduce Population Blood Pressure in Tibet: Tibet Salt Reduction Study
- ClinicalTrials.gov ID
- NCT02021435
- Acronym / sponsor ID
- 2013BAI05B04
- Conditions
- Blood Pressure, Cardiovascular Diseases, Death
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Collaborators
- The George Institute for Global Health at PUHSC, The George Institute for Global Health, Australia, Science and Technology Department of Ningxia, People's Hospital of Tibet, People's Hospital of Maizhokunggar, Tibet University, Peking University, People's Hospital of Damxung County, Tibet
- Study start
- Apr 2014
- Primary completion
- Mar 2016 (estimated)
- First posted
- 27 Dec 2013 (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.
- Research background
- High blood pressure is one of the most important risk factors to cardiovascular diseases (CVDs). Reducing population blood pressure can control CVD incidence and lower mortality effectively. Much research has proven that adjusting for Na and K intake level can reduce blood pressure. According to the China Salt Substitute Study, the systolic blood pressure of intervention group which used salt substitute is 5.4 mmHg lower than that of control group. Life expectancy in Tibet is 67 years old. It is estimated that the use of salt substitute among population in Tibet can reduce total mortality in Tibet by 20%. China Salt Substitute Study in Tibet (CSSS-Tibet), found that salt substitute is effective in lowering both systolic and diastolic blood pressure and offers a simple, low-cost approach for hypertension control among Tibetans in China (unpublished results). However, the study focused on hypertensive patients, the effectiveness of hypertension control by providing free salt substitute to the entire population remains unknown, and a large-scale trial is needed.
- Objectives
- Primary objective is to observe the effect of providing salt substitute on population blood pressure in Tibet. Secondary objective is to observe the effect of such intervention on population mortality, cardiovascular mortality and life expectancy. In addition, the data collected from high-risk population (sub-group) in the study will be used in China Salt Substitute and Stroke Study (SSaSS). Also, serum cholesterol and random blood glucose of people over 60 in Tibet will be collected.
- Method
- The study is a open, cluster-randomized, controlled trial.
- 30 villages with 15 to 35 households each and a distance of at least five kilometers in between will be selected from Damxung county and Maizhokunggar county. The two counties have an average altitude of over 4000 meters in Tibet Autonomous Region.
- All selected villages will be randomly assigned to intervention group or control group on a 1:1 ratio.
- All household in the selected villages will be recruited if they meet the eligibility criteria. Approximately 4,500 participants will be enrolled
- Intervention group receives free salt substitute. Control group will continue to buy their own normal salt. Both group will receive the same health education on salt reduction.
- Outcome - Primary outcome is blood pressure. Secondary outcomes include total mortality, cardiovascular disease mortality, life expectancy, serum cholesterol level of people over 60, and random blood glucose level of people over 60.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salt Substitute | Experimental | Dietary Supplement: salt substitutesalt substitute |
| Control | No intervention | –Participants continue to buy salt at their own expense |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- All family households in the selected satellite village will be invited to participate in the study
- Family households will be excluded from participating if they meet one or more of the following exclusion criteria:
- Any member in the family is using a potassium-sparing diuretic
- Any member in the family is using a potassium supplement
- Any member in the family has serious renal impairment
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| salt substituteFree salt substitute provided | Dietary supplement | Salt Substitute |
Primary outcome
Difference in change from baseline in blood pressure between intervention and control
Time frame: Baseline, 6,12, 24 months
5 secondary outcomes
Difference in total mortality between intervention and control
Time frame: 6, 12, 24 months
Difference in cardiovascular disease mortality between intervention and control
Time frame: 6,12, 24 months
Difference in life expectancy between intervention and control group
Time frame: 6, 12, 24 months
The distribution of blood glucose level in population over 60 years old
Time frame: baseline
Distribution of serum cholesterol level in population over 60 years old
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
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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.
Xingshan Zhao, M.D. principal investigator
Beijing Jishuitan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing salt substitute in people with Blood Pressure and Cardiovascular Diseases, run by Beijing Jishuitan Hospital at 2 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 7 inclusion and 0 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 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xingshan Zhao, M.D. (86-13701326978, xingshanzh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in change from baseline in blood pressure between intervention and control (time frame: Baseline, 6,12, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014.