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

2. november 2026 oppdatert av: Xianghui Zhang, Shihezi University

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

800

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Xinjiang
      • Shihezi, Xinjiang, Kina, 832000
        • Shihezi City People's Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Low-Sodium Salt Group
Kosttilskudd: 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.
Aktiv komparator: Regular Salt Group
Kosttilskudd: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of Participants With Failure of Hypertension Prevention or Control
Tidsramme: From randomization to Month 12

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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Shihezi University

Samarbeidspartnere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

20. september 2026

Først innsendt som oppfylte QC-kriteriene

20. september 2026

Først lagt ut (Faktiske)

25. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HOME-SALT-2026-01
  • KYLL-2026-61 (Annen identifikator: Shihezi City People's Hospital Ethics Committee)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ANALYTIC_CODE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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