Health TrialsbyHealthPanel

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

ConditionHypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShihezi University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Low-Sodium Salt GroupExperimental treatment 1 intervention
Group B: Regular Salt GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
From randomization to Month 12

Secondary outcomes

1

Proportion of Participants With Hypertension Who Have Controlled Blood Pressure at Month 12

Time frame
Month 12
2

Change in Systolic Blood Pressure Among Participants With Hypertension

Time frame
Baseline to Month 12
3

Change in Diastolic Blood Pressure Among Participants With Hypertension

Time frame
Baseline to Month 12
4

Proportion of Participants With Hypertension Who Have Controlled Mean Blood Pressure During Follow-up

Time frame
Months 3, 6, and 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shihezi University

Lead sponsor

The General Hospital of the Eighth Division (The Third Affiliated Hospital of Shihezi University Medical College)

Collaborator

Source ClinicalTrials.gov

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