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China Salt Substitute Study

This study has been completed.
Sponsor:
Collaborators:
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
First received: September 2, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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

Locations
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
China
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
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

No publications provided

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

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014