Status:
COMPLETED
China Salt Substitute Study
Lead Sponsor:
The George Institute
Collaborating Sponsors:
Fu Wai Cardiovascular Institute and Hospital
University of Auckland, New Zealand
Conditions:
Hypertension
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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 d...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00145756
Start Date
May 1 2004
End Date
September 1 2005
Last Update
September 5 2005
Active Locations (6)
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1
The Institute for Medical Science of Mudangjiang
Mudanjiang, Heilongjiang, China, 157000
2
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110000
3
The People's Hospital of YuXian
Yangquan, Shanxi, China, 045100
4
The Health Center of Fengbo,ShunYi District
Beijing, China, 101300