China Salt Substitute Study - Full Text View

Sponsors and Collaborators:	The George Institute Fu Wai Cardiovascular Institute and Hospital University of Auckland, New Zealand James Cook University, Queensland, Australia
Information provided by:	The George Institute
ClinicalTrials.gov Identifier:	NCT00145756

Purpose

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	Intervention
Hypertension Cardiovascular Diseases	Drug: low sodium high potassium salt substitute

MedlinePlus related topics: Dietary Sodium High Blood Pressure

Drug Information available for: Sodium chloride Chlorides Potassium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by The George Institute:

Primary Outcome Measures:

Clinical blood pressure

Secondary Outcome Measures:

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

Estimated Enrollment:	600
Study Start Date:	May 2004
Estimated Study Completion Date:	September 2005

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145756

Locations

China
The First Affiliated Hospital of Medical College of China's people Armed Police Force
Tianjin, China, 300000
The Health Center of YingHai, DaXing District
Beijing, China, 102600
The Health Center of Fengbo,ShunYi District
Beijing, China, 101300
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

Sponsors and Collaborators

The George Institute

Fu Wai Cardiovascular Institute and Hospital

University of Auckland, New Zealand

James Cook University, Queensland, Australia

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

More Information

Study ID Numbers:	CSSS
Study First Received:	September 2, 2005
Last Updated:	September 2, 2005
ClinicalTrials.gov Identifier:	NCT00145756
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by The George Institute:

Sodium Chloride
Blood Pressure
Cardiovascular Diseases
Clinical Trial

Study placed in the following topic categories:

Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009