HypertensionNCT00145756
China Salt Substitute Study
A study testing low sodium high potassium salt substitute in people with Hypertension and Cardiovascular Diseases, run by The George Institute at 6 sites in China.
Trial summary
Cardiovascular disease is a leading cause of death and disability worldwide, and blood pressure is a leading determinant of this risk. To date, strategies for blood pressure lowering have focused on drug treatment but dietary interventions such as reducing sodium intake and increasing potassium intake may also be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Cardiovascular Diseases
- What is being tested?
- low sodium high potassium salt substitute
- How many people
- 600 participants
- Where
- 6 sitesChina
- Study dates
- May 2004to Sep 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant inclusion will be based upon the presence of:
- A doctor-confirmed high risk of future vascular disease defined as a history of any one of:
- Stroke or transient ischaemic attack
- Hospitalisation for management of any acute coronary syndrome
- Surgery or angioplasty for peripheral vascular disease
- Treated diabetes and age 55 years or older
Show all 9Show fewer
- Systolic blood pressure >160mmHg
- Estimated daily sodium intake of 260mmol/24hrs (about 15g/24hrs of NaCl) or above and expectation that at least 50% of daily dietary salt intake can be replaced with the salt-substitute. This will be estimated through interview of the potential participant and the individual responsible for daily food preparation (if this is not the patient) using a structured questionnaire.
- Provision of informed consent
Who cannot join
- Potential participants will be excluded if:
- they are on potassium-sparing medication
- there is an established history of significant renal impairment that would preclude the use of the salt-substitute in the opinion of the responsible physician.
- there is any reason why either the salt-substitute or normal salt are definitely indicated or definitely contra-indicated.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
The Health Center of Fengbo,ShunYi District
Beijing, 101300
The Health Center of YingHai, DaXing District
Beijing, 102600
The Institute for Medical Science of Mudangjiang
Mudanjiang, Heilongjiang, 157000
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110000
The First Affiliated Hospital of Medical College of China's people Armed Police Force
Tianjin, 300000
The People's Hospital of YuXian
Yangquan, Shanxi, 045100
About this study
Official title: China Salt Substitute Study-A Randomised Trial to Determine the Long-Term Effects of a Low Sodium, High Potassium Salt Substitute on Blood Pressure Among High-Risk Individuals in Northern China
Cardiovascular disease is a leading cause of death and disability worldwide, and blood pressure is a leading determinant of this risk. To date, strategies for blood pressure lowering have focused on drug treatment but dietary interventions such as reducing sodium intake and increasing potassium intake may also be effective. Such interventions may be particularly suitable for low- and middle-income countries in which significant dietary changes may be more easily achieved. This study will test the effect of a salt substitute on blood pressure, among individuals at high-risk from cardiovascular disease in Northern China.
Read the detailed description
This randomised trial will clearly identify whether a low-sodium, high-potassium salt-substitute is a feasible means of lowering blood pressure in high-risk individuals in rural China. The randomised design and the large size (n=600) will ensure that the results are reliable and precise. The 12-month duration will address the long-term practicability of the intervention strategy. The study is being conducted because salt-substitute-based blood pressure lowering may be particularly appropriate for rural populations in low- and middle-income countries. First, sodium intake is often very high. Second, the salt-substitute can be easily incorporated into the diet because most food is prepared and eaten at home. Third, the intervention can be provided at very low cost.
Comparisions: Low sodium high potassium salt (65% sodium chloride, 25% potassium chloride, 10% magnesium sulphate) compared to normal salt (100% sodium chloride).
- Conditions
- Hypertension, Cardiovascular Diseases
- Being tested
- low sodium high potassium salt substitute
- Keywords
- Sodium Chloride, Blood Pressure, Cardiovascular Diseases, Clinical Trial
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low sodium high potassium salt substituteDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical blood pressure
Secondary outcomes (3)
Spot urine sodium and potassium levels
Food taste
Preferred level of saltiness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startMay 2004
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Fu Wai Cardiovascular Institute and Hospital, University of Auckland, New Zealand, James Cook University, Queensland, Australia
- Investigators
- Bruce C Neal, PhD, Principal investigator, The George InstituteYangfeng Wu, PhD, Principal investigator, Fu Wai Cardiovascular Institute, Beijing, ChinaRachel Huxley, PhD, Principal investigator, The George InstituteJohn Prescott, PhD, Principal investigator, James Cook University, Queensland, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145756
- Sponsor's protocol ID
- CSSS
- Status last verified
- Sep 2005
- First submitted
- 2 Sep 2005
- Last updated
- 5 Sep 2005
- Results posted
- No
Publications
Kissock K, Neal B, Yuan Y, Sundstrom J, Jonsson H, Rodgers A, Wang N, Huang L, Wu Y. Consistency of Blood Pressure Response to Potassium-Enriched Salt in the China Salt Substitute Study. Hypertension. 2026 Jan;83(1):167-176. doi: 10.1161/HYPERTENSIONAHA.125.24723. Epub 2025 Nov 20.
PubMed 41263071
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Salt Substitute Study-A Randomised Trial to Determine the Long-Term Effects of a Low Sodium, High Potassium Salt Substitute on Blood Pressure Among High-Risk Individuals in Northern China
- ClinicalTrials.gov ID
- NCT00145756
- Acronym / sponsor ID
- CSSS
- Conditions
- Hypertension, Cardiovascular Diseases
- Keywords
- Sodium Chloride, Blood Pressure, Cardiovascular Diseases, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- Fu Wai Cardiovascular Institute and Hospital, University of Auckland, New Zealand, James Cook University, Queensland, Australia
- Study start
- May 2004
- Study completion
- Sep 2005
- First posted
- 5 Sep 2005 (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.
Cardiovascular disease is a leading cause of death and disability worldwide, and blood pressure is a leading determinant of this risk. To date, strategies for blood pressure lowering have focused on drug treatment but dietary interventions such as reducing sodium intake and increasing potassium intake may also be effective. Such interventions may be particularly suitable for low- and middle-income countries in which significant dietary changes may be more easily achieved. This study will test the effect of a salt substitute on blood pressure, among individuals at high-risk from cardiovascular disease in Northern China.
Detailed description
This randomised trial will clearly identify whether a low-sodium, high-potassium salt-substitute is a feasible means of lowering blood pressure in high-risk individuals in rural China. The randomised design and the large size (n=600) will ensure that the results are reliable and precise. The 12-month duration will address the long-term practicability of the intervention strategy. The study is being conducted because salt-substitute-based blood pressure lowering may be particularly appropriate for rural populations in low- and middle-income countries. First, sodium intake is often very high. Second, the salt-substitute can be easily incorporated into the diet because most food is prepared and eaten at home. Third, the intervention can be provided at very low cost.
Comparisions: Low sodium high potassium salt (65% sodium chloride, 25% potassium chloride, 10% magnesium sulphate) compared to normal salt (100% sodium chloride).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A doctor-confirmed high risk of future vascular disease defined as a history of any one of:
- Estimated daily sodium intake of 260mmol/24hrs (about 15g/24hrs of NaCl) or above and expectation that at least 50% of daily dietary salt intake can be replaced with the salt-substitute. This will be estimated through interview of the potential participant and the individual responsible for daily food preparation (if this is not the patient) using a structured questionnaire.
- Provision of informed consent
Key exclusion criteria (4 listed)
- they are on potassium-sparing medication
- there is an established history of significant renal impairment that would preclude the use of the salt-substitute in the opinion of the responsible physician.
- there is any reason why either the salt-substitute or normal salt are definitely indicated or definitely contra-indicated.
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 |
|---|---|---|
| low sodium high potassium salt substitute | Drug | – |
Primary outcome
Clinical blood pressure
3 secondary outcomes
Spot urine sodium and potassium levels
Food taste
Preferred level of saltiness
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 5 Sep 2005.
- Derived from this study: PubMed 41263071Kissock K, Neal B, Yuan Y, Sundstrom J, Jonsson H, Rodgers A, Wang N, Huang L, Wu Y. Consistency of Blood Pressure Response to Potassium-Enriched Salt in the China Salt Substitute Study. Hypertension. 2026 Jan;83(1):167-176. doi: 10.1161/HYPERTENSIONAHA.125.24723. Epub 2025 Nov 20.
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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.
Bruce C Neal, PhD principal investigator
The George Institute
Yangfeng Wu, PhD principal investigator
Fu Wai Cardiovascular Institute, Beijing, China
Rachel Huxley, PhD principal investigator
The George Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low sodium high potassium salt substitute in people with Hypertension and Cardiovascular Diseases, run by The George Institute at 6 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 9 inclusion and 4 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 5 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Clinical blood pressure. 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 NCT00145756, which also lists 1 linked publication.
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 5 Sep 2005.