NCT07840742Not yet recruiting
Household Salt Substitution for Hypertension Prevention and Control: The HOME-Salt Trial
Household-Oriented Salt Substitution for CoMprehensive Hypertension PrEvention and Control: A Cluster-Randomized, Double-Blind Controlled Trial (HOME-Salt Trial)
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 800 (estimated)
- First submitted
- 20 Sept 2026
- Start date
- Nov 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Shihezi University
- Diseases
- High blood pressure
- NCT number
- NCT07840742
What you commit to
- Study type: Interventional
- Planned participants: 800
- From Nov 2026 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Serious cardiovascular or cerebrovascular disease, severe liver disease, malignant tumor, severe mental illness, cognitive impairment, or another condition considered unsuitable for study participation.
- Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation.
Lab values
- 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.
- Currently participating in another interventional study that may affect blood pressure, sodium or potassium intake, or study outcomes.
Other
- Household-level criteria:
- Any household member who routinely shares meals is pregnant.
- Any household member who routinely shares meals has hyperthyroidism.
- Participant-level criteria:
- Unable to complete follow-up visits, standardized blood pressure measurements, or required data collection.
Who the study is looking for
- 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:
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shihezi City People's Hospital Coordinator of this site? Confirm its status | Shihezi | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.