China Salt Substitute Study

China Salt Substitute Study-A Randomised Trial to Determine the Long-Term Effects of a Low Sodium, High Potassium Salt Substitute on Blood Pressure Among High-Risk Individuals in Northern China

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Hypertension
• Intervention / Treatment: Drug: low sodium high potassium salt substitute

Detailed Description

This randomised trial will clearly identify whether a low-sodium, high-potassium salt-substitute is a feasible means of lowering blood pressure in high-risk individuals in rural China. The randomised design and the large size (n=600) will ensure that the results are reliable and precise. The 12-month duration will address the long-term practicability of the intervention strategy. The study is being conducted because salt-substitute-based blood pressure lowering may be particularly appropriate for rural populations in low- and middle-income countries. First, sodium intake is often very high. Second, the salt-substitute can be easily incorporated into the diet because most food is prepared and eaten at home. Third, the intervention can be provided at very low cost.

Comparisions: Low sodium high potassium salt (65% sodium chloride, 25% potassium chloride, 10% magnesium sulphate) compared to normal salt (100% sodium chloride).

• Study Type: Interventional
• Enrollment: 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 101300
    • The Health Center of Fengbo,ShunYi District
  • Beijing, China, 102600
    • The Health Center of YingHai, DaXing District
  • Tianjin, China, 300000
    • The First Affiliated Hospital of Medical College of China's people Armed Police Force
  • Heilongjiang
    • Mudanjiang, Heilongjiang, China, 157000
      • The Institute for Medical Science of Mudangjiang
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • The first affiliated hospital of China medical university
  • Shanxi
    • Yangquan, Shanxi, China, 045100
      • The People's Hospital of YuXian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Participant inclusion will be based upon the presence of:

• 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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical blood pressure

Secondary Outcome Measures

Outcome Measure
Spot urine sodium and potassium levels
Food taste
Preferred level of saltiness

Collaborators and Investigators

• Sponsor: The George Institute
• Collaborators: University of Auckland, New Zealand; James Cook University, Queensland, Australia; Fu Wai Cardiovascular Institute and Hospital
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Study Completion: September 1, 2005

Study Registration Dates

• First Submitted: September 2, 2005
• First Submitted That Met QC Criteria: September 2, 2005
• First Posted (Estimate): September 5, 2005

Study Record Updates

• Last Update Posted (Estimate): September 5, 2005
• Last Update Submitted That Met QC Criteria: September 2, 2005
• Last Verified: September 1, 2005

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Clinical Trial; Blood Pressure; Sodium Chloride
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: CSSS