China Salt Substitute Study

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00145756
• Other study ID #: CSSS
• Status: Completed
• Phase: N/A
• First received: September 2, 2005
• Last updated: September 2, 2005
• Start date: May 2004
• Est. completion date: September 2005

Study information

• Verified date: September 2005
• Source: The George Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension

Intervention

Drug:
• low sodium high potassium salt substitute

Locations

Country	Name	City	State
China	The Health Center of Fengbo,ShunYi District	Beijing
China	The Health Center of YingHai, DaXing District	Beijing
China	The Institute for Medical Science of Mudangjiang	Mudanjiang	Heilongjiang
China	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	The First Affiliated Hospital of Medical College of China's people Armed Police Force	Tianjin
China	The People's Hospital of YuXian	Yangquan	Shanxi

Sponsors (4)

Lead Sponsor	Collaborator
The George Institute	Fu Wai Cardiovascular Institute and Hospital, James Cook University, Queensland, Australia, University of Auckland, New Zealand

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical blood pressure
Secondary	Spot urine sodium and potassium levels
Secondary	Food taste
Secondary	Preferred level of saltiness