HypertensionHOME-SaltNCT07840742
Household Salt Substitution for Hypertension Prevention and Control: The HOME-Salt Trial
A study testing Low-Sodium Salt Substitute and Regular Salt in people with Hypertension, run by Shihezi University at 1 site in China.
Trial summary
Hypertension is a major risk factor for cardiovascular disease. Excess sodium intake and insufficient potassium intake contribute to elevated blood pressure, while replacing regular salt with a potassium-enriched salt substitute may help lower blood pressure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Low-Sodium Salt Substitute and Regular Salt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- Nov 2026to Dec 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Household-level criteria:
- The household includes at least one adult aged 18 years or older with diagnosed hypertension.
- The household includes at least one adult aged 18 years or older without hypertension at baseline.
- Household members primarily share cooking and meals.
- All adult household members intended to be included in study evaluations provide written informed consent.
- Participant-level criteria:
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- Aged 18 years or older.
- Long-term resident of the study area with no plan to move away during the following 12 months.
- Consumes most meals at home.
- Provides written informed consent.
Who cannot join
- Household-level criteria:
- The household is currently using low-sodium salt or another potassium-containing salt substitute on a long-term basis.
- Any household member who routinely shares meals has a contraindication to potassium-enriched salt or is at increased risk of hyperkalemia, including chronic kidney disease, estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m², a history of dialysis, or a history of hyperkalemia.
- Any household member who routinely shares meals is pregnant.
- Any household member who routinely shares meals has hyperthyroidism.
- Participant-level criteria:
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- Currently participating in another interventional study that may affect blood pressure, sodium or potassium intake, or study outcomes.
- Serious cardiovascular or cerebrovascular disease, severe liver disease, malignant tumor, severe mental illness, cognitive impairment, or another condition considered unsuitable for study participation.
- Unable to complete follow-up visits, standardized blood pressure measurements, or required data collection.
- Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shihezi City People's Hospital
Shihezi, Xinjiang, 832000
Qiang Zhang, Master, +8613899513431, zhqiang120@126.com
About this study
Official title: Household-Oriented Salt Substitution for CoMprehensive Hypertension PrEvention and Control: A Cluster-Randomized, Double-Blind Controlled Trial (HOME-Salt Trial)
Hypertension is a major risk factor for cardiovascular disease. Excess sodium intake and insufficient potassium intake contribute to elevated blood pressure, while replacing regular salt with a potassium-enriched salt substitute may help lower blood pressure. Because cooking salt is commonly shared within households, a household-based salt substitution strategy may provide benefits not only for people with hypertension but also for family members who have not yet developed hypertension.
The HOME-Salt Trial is a cluster-randomized, double-blind controlled trial designed to evaluate the effects of household salt substitution on hypertension prevention and control. Eligible households will include at least one adult with diagnosed hypertension and at least one adult without hypertension at baseline. Households will be randomly assigned in a 1:1 ratio to receive either a low-sodium salt substitute or regular salt for 12 months.
Approximately 400 households, including at least 800 adults, will be enrolled. Participants, field staff, and outcome assessors will be unaware of treatment assignment. Follow-up assessments will be conducted at 3, 6, and 12 months. The study will evaluate whether household use of low-sodium salt improves blood pressure control among adults with hypertension and reduces the development of hypertension among adults without hypertension at baseline. Blood pressure, medication use, sodium and potassium intake indicators, safety outcomes, and other health-related measures will also be assessed.
- Conditions
- Hypertension
- Being tested
- Low-Sodium Salt Substitute, Regular Salt
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Sodium Salt SubstituteDietary supplement
Low-sodium salt containing approximately 75% sodium chloride and 25% potassium chloride. It will replace the household's usual cooking and table salt throughout the 12-month intervention period.
Regular SaltDietary supplement
Regular salt containing approximately 99.8% sodium chloride. It will replace the household's usual cooking and table salt throughout the 12-month intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Low-Sodium Salt Group | Experimental | Not described Receives: Dietary Supplement: Low-Sodium Salt Substitute |
| Regular Salt Group | Active comparator | Not described Receives: Dietary Supplement: Regular Salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Failure of Hypertension Prevention or Control
A participant-level composite outcome. For participants with hypertension at baseline, failure of hypertension control is defined as a mean systolic blood pressure (SBP) ≥140 mmHg and/or mean diastolic blood pressure (DBP) ≥90 mmHg based on three standardized office blood pressure measurements at Month 12. For participants without hypertension at baseline, failure of hypertension prevention is defined as incident hypertension during follow-up, including a mean SBP ≥140 mmHg and/or mean DBP ≥90 mmHg based on three standardized office measurements, a new diagnosis of hypertension, or initiation of antihypertensive medication.
Measured: From randomization to Month 12
Secondary outcomes (8)
Proportion of Participants With Hypertension Who Have Controlled Blood Pressure at Month 12
Measured: Month 12
Change in Systolic Blood Pressure Among Participants With Hypertension
Measured: Baseline to Month 12
Change in Diastolic Blood Pressure Among Participants With Hypertension
Measured: Baseline to Month 12
Proportion of Participants With Hypertension Who Have Controlled Mean Blood Pressure During Follow-up
Measured: Months 3, 6, and 12
Incidence of Hypertension Among Participants Without Hypertension at Baseline
Measured: From randomization to Month 12
Change in Systolic Blood Pressure Among Participants Without Hypertension at Baseline
Measured: Baseline to Month 12
Change in Diastolic Blood Pressure Among Participants Without Hypertension at Baseline
Measured: Baseline to Month 12
Proportion of Households With Successful Hypertension Prevention and Control
Measured: From randomization to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shihezi University
- Sponsor type
- University, hospital or other
- Collaborators
- The General Hospital of the Eighth Division (The Third Affiliated Hospital of Shihezi University Medical College)
- Responsible party
- Principal investigator, Xianghui Zhang, Shihezi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840742
- Sponsor's protocol ID
- HOME-SALT-2026-01
- Other IDs
- KYLL-2026-61
- Acronym
- HOME-Salt
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data underlying the results reported in publications from this trial may be shared with qualified researchers upon reasonable request and approval by the study investigators. Data sharing will be subject to applicable ethical, privacy, and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Household-Oriented Salt Substitution for CoMprehensive Hypertension PrEvention and Control: A Cluster-Randomized, Double-Blind Controlled Trial (HOME-Salt Trial)
- ClinicalTrials.gov ID
- NCT07840742
- Acronym / sponsor ID
- HOME-Salt / HOME-SALT-2026-01
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Shihezi UniversityUniversity, hospital or other
- Collaborators
- The General Hospital of the Eighth Division (The Third Affiliated Hospital of Shihezi University Medical College)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Sep 2026 (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.
Hypertension is a major risk factor for cardiovascular disease. Excess sodium intake and insufficient potassium intake contribute to elevated blood pressure, while replacing regular salt with a potassium-enriched salt substitute may help lower blood pressure. Because cooking salt is commonly shared within households, a household-based salt substitution strategy may provide benefits not only for people with hypertension but also for family members who have not yet developed hypertension.
The HOME-Salt Trial is a cluster-randomized, double-blind controlled trial designed to evaluate the effects of household salt substitution on hypertension prevention and control. Eligible households will include at least one adult with diagnosed hypertension and at least one adult without hypertension at baseline. Households will be randomly assigned in a 1:1 ratio to receive either a low-sodium salt substitute or regular salt for 12 months.
Approximately 400 households, including at least 800 adults, will be enrolled. Participants, field staff, and outcome assessors will be unaware of treatment assignment. Follow-up assessments will be conducted at 3, 6, and 12 months. The study will evaluate whether household use of low-sodium salt improves blood pressure control among adults with hypertension and reduces the development of hypertension among adults without hypertension at baseline. Blood pressure, medication use, sodium and potassium intake indicators, safety outcomes, and other health-related measures will also be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Sodium Salt Group | Experimental | Dietary Supplement: Low-Sodium Salt Substitute |
| Regular Salt Group | Active comparator | Dietary Supplement: Regular Salt |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The household includes at least one adult aged 18 years or older with diagnosed hypertension.
- The household includes at least one adult aged 18 years or older without hypertension at baseline.
- Household members primarily share cooking and meals.
- All adult household members intended to be included in study evaluations provide written informed consent.
- Aged 18 years or older.
Key exclusion criteria (10 listed)
- The household is currently using low-sodium salt or another potassium-containing salt substitute on a long-term basis.
- Any household member who routinely shares meals has a contraindication to potassium-enriched salt or is at increased risk of hyperkalemia, including chronic kidney disease, estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m², a history of dialysis, or a history of hyperkalemia.
- Any household member who routinely shares meals is pregnant.
- Any household member who routinely shares meals has hyperthyroidism.
- Currently participating in another interventional study that may affect blood pressure, sodium or potassium intake, or study outcomes.
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 Salt SubstituteLow-sodium salt containing approximately 75% sodium chloride and 25% potassium chloride. It will replace the household's usual cooking and table salt throughout the 12-month intervention period. | Dietary supplement | Low-Sodium Salt Group |
| Regular SaltRegular salt containing approximately 99.8% sodium chloride. It will replace the household's usual cooking and table salt throughout the 12-month intervention period. | Dietary supplement | Regular Salt Group |
Primary outcome
Proportion of Participants With Failure of Hypertension Prevention or Control
Time frame: From randomization to Month 12
A participant-level composite outcome. For participants with hypertension at baseline, failure of hypertension control is defined as a mean systolic blood pressure (SBP) ≥140 mmHg and/or mean diastolic blood pressure (DBP) ≥90 mmHg based on three standardized office blood pressure measurements at Month 12. For participants without hypertension at baseline, failure of hypertension prevention is defined as incident hypertension during follow-up, including a mean SBP ≥140 mmHg and/or mean DBP ≥90 mmHg based on three standardized office measurements, a new diagnosis of hypertension, or initiation of antihypertensive medication.
8 secondary outcomes
Proportion of Participants With Hypertension Who Have Controlled Blood Pressure at Month 12
Time frame: Month 12
Change in Systolic Blood Pressure Among Participants With Hypertension
Time frame: Baseline to Month 12
Change in Diastolic Blood Pressure Among Participants With Hypertension
Time frame: Baseline to Month 12
Proportion of Participants With Hypertension Who Have Controlled Mean Blood Pressure During Follow-up
Time frame: Months 3, 6, and 12
Incidence of Hypertension Among Participants Without Hypertension at Baseline
Time frame: From randomization to Month 12
Change in Systolic Blood Pressure Among Participants Without Hypertension at Baseline
Time frame: Baseline to Month 12
Change in Diastolic Blood Pressure Among Participants Without Hypertension at Baseline
Time frame: Baseline to Month 12
Proportion of Households With Successful Hypertension Prevention and Control
Time frame: From randomization to Month 12
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 3 Nov 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data underlying the results reported in publications from this trial may be shared with qualified researchers upon reasonable request and approval by the study investigators. Data sharing will be subject to applicable ethical, privacy, and institutional requirements.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Sodium Salt Substitute and Regular Salt in people with Hypertension, run by Shihezi University at 1 site 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 10 inclusion and 10 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 Xianghui Zhang, PhD (+8618999335467, zxh818@shzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Failure of Hypertension Prevention or Control (time frame: From randomization to Month 12). 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 3 Nov 2026.