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NCT07840742
Household Salt Substitution for Hypertension Prevention and Control: The HOME-Salt Trial
Conditions: Hypertension
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 800
Sponsor: Shihezi University
Location: Shihezi City People's Hospital Shihezi Xinjiang
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. 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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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) \
Source: ClinicalTrials.gov (NCT07840742). StuddyBuddy aggregates publicly available trial information.