An interventional study of Low-Sodium Salt Substitute and Regular Salt in Hypertension, sponsored by Shihezi University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Shihezi University · Not applicable, Interventional, and Other
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 800 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Shihezi University is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Sep 30, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Household-level criteria:
Participant-level criteria:
Exclusion Criteria:
Household-level criteria:
Participant-level criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Low-Sodium Salt Substitute
Dietary Supplement: Regular Salt
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 salt containing approximately 99.8% sodium chloride. It will replace the household's usual cooking and table salt throughout the 12-month intervention period.
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.
Time frame: From randomization to Month 12
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
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Beginning 12 months after publication of the primary study results and available for 5 years
Access criteria: Deidentified individual participant data and supporting information may be made available to qualified researchers upon reasonable request. Requests will be reviewed by the study investigators and, where applicable, relevant institutional or ethics committees. Data will be shared only for scientifically appropriate purposes and subject to an appropriate data use agreement.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 13 months is below that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Nov 3, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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