China Salt Substitute Study

NCT ID: NCT00145756

Last Updated: 2005-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2005-09-30

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.

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).

Conditions

Hypertension; Cardiovascular Diseases

Keywords

Sodium Chloride; Blood Pressure; Cardiovascular Diseases; Clinical Trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

low sodium high potassium salt substitute

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fu Wai Cardiovascular Institute and Hospital

UNKNOWN

Sponsor Role: collaborator

University of Auckland, New Zealand

OTHER

Sponsor Role: collaborator

James Cook University, Queensland, Australia

OTHER

Sponsor Role: collaborator

The George Institute

OTHER

Sponsor Role: lead

Principal Investigators

Bruce C Neal, PhD

Role: PRINCIPAL_INVESTIGATOR

The George Institute

Yangfeng Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

Fu Wai Cardiovascular Institute, Beijing, China

Rachel Huxley, PhD

Role: PRINCIPAL_INVESTIGATOR

The George Institute

John Prescott, PhD

Role: PRINCIPAL_INVESTIGATOR

James Cook University, Queensland, Australia

Locations

The Institute for Medical Science of Mudangjiang

Mudanjiang, Heilongjiang, China

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

The People's Hospital of YuXian

Yangquan, Shanxi, China

The Health Center of Fengbo,ShunYi District

Beijing, , China

The Health Center of YingHai, DaXing District

Beijing, , China

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

Tianjin, , China

Countries

China

Other Identifiers

CSSS

Identifier Type: -

Identifier Source: org_study_id