China Salt Substitute Study
| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | September 2, 2005 | ||||||||||||||||
| Last Updated Date | September 2, 2005 | ||||||||||||||||
| Start Date ICMJE | May 2004 | ||||||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Clinical blood pressure | ||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | No Changes Posted | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | China Salt Substitute Study | ||||||||||||||||
| Official Title ICMJE | 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 | ||||||||||||||||
| 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. |
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| 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). |
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| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: low sodium high potassium salt substitute | ||||||||||||||||
| Study Arm (s) | Not Provided | ||||||||||||||||
| Publications * | Not Provided | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||
| Enrollment ICMJE | 600 | ||||||||||||||||
| Completion Date | September 2005 | ||||||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Participant inclusion will be based upon the presence of:
Exclusion Criteria: Potential participants will be excluded if:
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| Gender | Both | ||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | China | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT00145756 | ||||||||||||||||
| Other Study ID Numbers ICMJE | CSSS | ||||||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||||||
| Responsible Party | Not Provided | ||||||||||||||||
| Study Sponsor ICMJE | The George Institute | ||||||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | The George Institute | ||||||||||||||||
| Verification Date | September 2005 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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