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

NCT07840742 | Not Yet Recruiting DMC

• 2 other identifiers: HOME-SALT-2026-01KYLL-2026-61
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (2)

Low-Sodium Salt Group

EXPERIMENTAL

Dietary Supplement: Low-Sodium Salt Substitute

Regular Salt Group

ACTIVE COMPARATOR

Dietary Supplement: Regular Salt

Interventions

Low-Sodium Salt Substitute DIETARY_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.

Low-Sodium Salt Group

Regular Salt DIETARY_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.

Regular Salt Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Shihezi City People's Hospital

Shihezi, Xinjiang, 832000, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Xianghui Zhang, PhD

CONTACT

+8618999335467; zxh818@shzu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 20, 2026
• First Posted: September 25, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

CN (1)