China Salt Substitute Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00145756
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : September 5, 2005
Fu Wai Cardiovascular Institute and Hospital
University of Auckland, New Zealand
James Cook University, Queensland, Australia
Information provided by:
The George Institute

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.

Condition or disease Intervention/treatment Phase
Hypertension Cardiovascular Diseases Drug: low sodium high potassium salt substitute Not Applicable

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  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: 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
Study Start Date : May 2004
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium Sodium

Primary Outcome Measures :
  1. Clinical blood pressure

Secondary Outcome Measures :
  1. Spot urine sodium and potassium levels
  2. Food taste
  3. Preferred level of saltiness

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00145756

China, Heilongjiang
The Institute for Medical Science of Mudangjiang
Mudanjiang, Heilongjiang, China, 157000
China, Liaoning
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110000
China, Shanxi
The People's Hospital of YuXian
Yangquan, Shanxi, China, 045100
The Health Center of Fengbo,ShunYi District
Beijing, China, 101300
The Health Center of YingHai, DaXing District
Beijing, China, 102600
The First Affiliated Hospital of Medical College of China's people Armed Police Force
Tianjin, China, 300000
Sponsors and Collaborators
The George Institute
Fu Wai Cardiovascular Institute and Hospital
University of Auckland, New Zealand
James Cook University, Queensland, Australia
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 Identifier: NCT00145756     History of Changes
Other Study ID Numbers: CSSS
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: September 5, 2005
Last Verified: September 2005

Keywords provided by The George Institute:
Sodium Chloride
Blood Pressure
Cardiovascular Diseases
Clinical Trial

Additional relevant MeSH terms:
Cardiovascular Diseases