NCT00145756

Brief Summary

Cardiovascular disease is a leading cause of death and disability worldwide, and blood pressure is a leading determinant of this risk. To date, strategies for blood pressure lowering have focused on drug treatment but dietary interventions such as reducing sodium intake and increasing potassium intake may also be effective. Such interventions may be particularly suitable for low- and middle-income countries in which significant dietary changes may be more easily achieved. This study will test the effect of a salt substitute on blood pressure, among individuals at high-risk from cardiovascular disease in Northern China.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started May 2004

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
Last Updated

September 5, 2005

Status Verified

September 1, 2005

First QC Date

September 2, 2005

Last Update Submit

September 2, 2005

Conditions

HypertensionCardiovascular Diseases

Keywords

Sodium ChlorideBlood PressureCardiovascular DiseasesClinical Trial

Outcome Measures

Primary Outcomes (1)

  • Clinical blood pressure

Secondary Outcomes (3)

  • Spot urine sodium and potassium levels

  • Food taste

  • Preferred level of saltiness

Interventions

low sodium high potassium salt substituteDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A doctor-confirmed high risk of future vascular disease defined as a history of any one of:
  • Stroke or transient ischaemic attack
  • Hospitalisation for management of any acute coronary syndrome
  • Surgery or angioplasty for peripheral vascular disease
  • Treated diabetes and age 55 years or older
  • Systolic blood pressure \>160mmHg
  • Estimated daily sodium intake of 260mmol/24hrs (about 15g/24hrs of NaCl) or above and expectation that at least 50% of daily dietary salt intake can be replaced with the salt-substitute. This will be estimated through interview of the potential participant and the individual responsible for daily food preparation (if this is not the patient) using a structured questionnaire.
  • Provision of informed consent

You may not qualify if:

  • Potential participants will be excluded if:
  • they are on potassium-sparing medication
  • there is an established history of significant renal impairment that would preclude the use of the salt-substitute in the opinion of the responsible physician.
  • there is any reason why either the salt-substitute or normal salt are definitely indicated or definitely contra-indicated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The Institute for Medical Science of Mudangjiang

Mudanjiang, Heilongjiang, 157000, China

Location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

The People's Hospital of YuXian

Yangquan, Shanxi, 045100, China

Location

The Health Center of Fengbo,ShunYi District

Beijing, 101300, China

Location

The Health Center of YingHai, DaXing District

Beijing, 102600, China

Location

The First Affiliated Hospital of Medical College of China's people Armed Police Force

Tianjin, 300000, China

Location

Related Publications (1)

  • Kissock K, Neal B, Yuan Y, Sundstrom J, Jonsson H, Rodgers A, Wang N, Huang L, Wu Y. Consistency of Blood Pressure Response to Potassium-Enriched Salt in the China Salt Substitute Study. Hypertension. 2026 Jan;83(1):167-176. doi: 10.1161/HYPERTENSIONAHA.125.24723. Epub 2025 Nov 20.

    PMID: 41263071DERIVED

MeSH Terms

Conditions

HypertensionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

  • Bruce C Neal, PhD

    The George Institute

    PRINCIPAL INVESTIGATOR

  • Yangfeng Wu, PhD

    Fu Wai Cardiovascular Institute, Beijing, China

    PRINCIPAL INVESTIGATOR

  • Rachel Huxley, PhD

    The George Institute

    PRINCIPAL INVESTIGATOR

  • John Prescott, PhD

    James Cook University, Queensland, Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

May 1, 2004

Study Completion

September 1, 2005

Last Updated

September 5, 2005

Record last verified: 2005-09

Locations

CN(6)