Household Salt Substitution for Hypertension Prevention and Control: The HOME-Salt Trial (HOME-Salt)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Dietary supplement: Low-Sodium Salt Substitute; Dietary supplement: Regular Salt

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xianghui Zhang, PhD; Phone Number: +8618999335467; Email: zxh818@shzu.edu.cn

Study Locations

• China
  • Xinjiang
    • Shihezi, Xinjiang, China, 832000
      • Shihezi City People's Hospital
      • Contact: Qiang Zhang, Master; Phone Number: +8613899513431; Email: zhqiang120@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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) <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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-Sodium Salt Group	Dietary supplement: Low-Sodium Salt Substitute; 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.
Active Comparator: Regular Salt Group	Dietary supplement: Regular Salt; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From randomization to Month 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of Participants With Hypertension Who Have Controlled Blood Pressure at Month 12	Month 12
Change in Systolic Blood Pressure Among Participants With Hypertension	Baseline to Month 12
Change in Diastolic Blood Pressure Among Participants With Hypertension	Baseline to Month 12
Proportion of Participants With Hypertension Who Have Controlled Mean Blood Pressure During Follow-up	Months 3, 6, and 12
Incidence of Hypertension Among Participants Without Hypertension at Baseline	From randomization to Month 12
Change in Systolic Blood Pressure Among Participants Without Hypertension at Baseline	Baseline to Month 12
Change in Diastolic Blood Pressure Among Participants Without Hypertension at Baseline	Baseline to Month 12
Proportion of Households With Successful Hypertension Prevention and Control	From randomization to Month 12

Collaborators and Investigators

• Sponsor: Shihezi University
• Collaborators: The General Hospital of the Eighth Division (The Third Affiliated Hospital of Shihezi University Medical College)

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 20, 2026
• First Submitted That Met QC Criteria: September 20, 2026
• First Posted (Actual): September 25, 2026

Study Record Updates

• Last Update Posted (Actual): November 3, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: HOME-SALT-2026-01; KYLL-2026-61 (Other Identifier: Shihezi City People's Hospital Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning 12 months after publication of the primary study results and available for 5 years

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No