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China Salt Substitute and Stroke Study (SSaSS)

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ClinicalTrials.gov Identifier: NCT02092090
Recruitment Status : Active, not recruiting
First Posted : March 19, 2014
Last Update Posted : August 3, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
The study is a large scale cluster randomised trial to evaluate the effects of sodium reduction based upon the use of salt substitute on the risk of stroke defined as the occurrence of stroke and stroke deaths. The corresponding null hypothesis that will be tested is that sodium reduction will have no effect upon stroke risk. The secondary objectives are to determine effects of sodium reduction on major vascular events and total mortality.

Condition or disease Intervention/treatment
Stroke Behavioral: Dietary sodium reduction

Detailed Description:
Lowering sodium intake and the use of salt substitute have been proved to lower blood pressure levels. Effects on the risks of vascular outcomes have not been defined in an adequately powered randomised trial. Rural Chinese are known to consume very large quantities of sodium and to suffer from very high rates of hypertension and stroke. This study is a large scale cluster randomised trial done in rural areas of China. The study will define the effects of a salt substitute-based sodium reduction strategy on the primary outcome of stroke. Secondary endpoints will include major cardiovascular events and total mortality. The study will be conducted in 600 rural villages across five Northern Chinese provinces and Tibet. The study will recruit 35 individuals at elevated risk of stroke from each village for a total of 21,000 participants. The participating villages will be randomised into intervention and control group with 1:1 allocation. Recruitment will prioritise individuals with a history of stroke but also include older individuals with high blood pressure. Follow up is scheduled for 5 years. Individuals in intervention villages will receive repeated dietary advice and a supply of low sodium salt substitute while individuals in control villages will receive dietary advice at baseline only. Every 6 months throughout follow-up each individual will be contacted by phone call to inquire about the occurrence of stroke, hospitalisation for any cause and diagnoses of any other serious illnesses. The interview will be structured and done by individuals masked to the randomised assignment of each individual. For all deaths identified and all events that might possibly be non-fatal strokes a home visit will be made. A series of process indicators including urinary sodium, urinary potassium, blood pressure, knowledge about sodium and use of salt substitute will also be measured on a random sample of at least 20 individuals drawn from a random selection of 60 villages at baseline and every year thereafter.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : March 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium Sodium
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Control
Dietary advice at baseline only
Experimental: Dietary sodium reduction
Dietary advice and reduced-sodium added-potassium salt substitute
Behavioral: Dietary sodium reduction
Ongoing dietary advice and a supply of a reduced-sodium added-potassium salt substitute
Other Name: Reduced-sodium added-potassium salt substitute

Outcome Measures

Primary Outcome Measures :
  1. Stroke [ Time Frame: 5 years ]
    The primary outcome will be stroke defined according to standard criteria on the basis of an acute disturbance of focal neurological function and resulting in death or symptoms lasting more than 24 hours. Imaging, clinical and laboratory data will be collected wherever possible.

Secondary Outcome Measures :
  1. Total major vascular events [ Time Frame: 5 years ]
    The composite of stroke, acute coronary syndrome or vascular death

  2. Total mortality [ Time Frame: 5 years ]

Other Outcome Measures:
  1. Blood Pressure [ Time Frame: 5 years ]
  2. Urinary sodium excretion [ Time Frame: 5 years ]
  3. Urinary Potassium [ Time Frame: 5 years ]
  4. Knowledge about sodium and salt substitute [ Time Frame: 5 years ]

    Knowledge about sodium and salt substitute will be measured using the following questions at baseline and follow-up:.

    Is a high salt intake good for your health? Does how much salt you eat affect your blood pressure? Does how much salt you eat affect your risk of stroke? What is the daily recommended salt intake for adults? Do you try to reduce the amount of salt you eat? Do you eat pickled vegetables most days? Do you add salt to most meals? Do you add mono-sodium glutamate to most meals? Do you try to eat less of a food if it is very salty? Have you heard about low sodium salt? If yes,does your household use low-sodium salt?

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Disease history
  • Prior stroke and/or
  • Aged 60 years or over and with uncontrolled high blood pressure (systolic blood pressure >=140 millimeters of mercury (mmHg) at visit if on blood pressure lowering medication; systolic blood pressure>=160 millimeters of mercury (mmHg) if not on blood pressure lowering medication)
  • Ownership of a phone by the participant or a household member

Exclusion Criteria:

  • Participant or family member is using a potassium-sparing diuretic
  • Participant or family member is using a potassium supplement
  • Participant or family member has serious renal impairment
  • Participant or family member has other reason for concern about use of salt substitute
  • Participant eats most meals outside the home
  • Participant is not expected to live longer than 6 months from the date of assessment as estimated by the village doctor
  • Another family member living in the same household has already been included in the study
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092090

China, Hebei
Hebei Province Centre for Disease Control and Prevention
Shijiazhuang, Hebei, China, 71000
China, Liaoning
China Medical Universtity
Shenyang, Liaoning, China, 110001
China, Ningxia
Ningxia Medical University
Yinchuan, Ningxia, China, 750004
China, Shaanxi
Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710049
China, Shanxi
Changzhi Medical Colledge
Changzhi, Shanxi, China, 046000
Sponsors and Collaborators
The George Institute
Peking University
Northwestern University
Imperial College London
China Medical University, China
Changzhi Medical College
Centers for Disease Control and Prevention, China
Ningxia Medical University
Health Science Center of Xi’an Jiaotong University
Principal Investigator: Bruce C Neal, PhD The George Institute for Global Health, Australia
Principal Investigator: Yangfeng Wu, PhD The George Institute for Global Health at Peking University Health Science Centre
Principal Investigator: Darwin Labarthe, PhD Feinberg School of Medicine, Northwestern University
Principal Investigator: Paul Elliott, PhD School of Public Health, Imperial College London
Principal Investigator: Lijing L Yan, PhD The George Institute for Global Health at Peking University Health Science Centre
Principal Investigator: Nicole Y Li, PhD The George Institute for Global Health, Australia
More Information

Responsible Party: The George Institute
ClinicalTrials.gov Identifier: NCT02092090     History of Changes
Other Study ID Numbers: SSaSS
Grant ID 1049417 ( Other Grant/Funding Number: Australian National Health and Medical Research Council )
First Posted: March 19, 2014    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: June 2015

Keywords provided by The George Institute:
salt substitute
sodium reduction
cluster randomized trial

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases