China Salt Substitute and Stroke Study (SSaSS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by The George Institute
Sponsor:
Collaborators:
Peking University
Northwestern University
Imperial College London
China Medical University, China
Changzhi Medical College
Hebei Province Centre for Disease Control and Prevention
Ningxia Medical University
Xi’an Jiaotong University College of Medicine
Information provided by (Responsible Party):
The George Institute
ClinicalTrials.gov Identifier:
NCT02092090
First received: March 12, 2014
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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 Intervention
Stroke
Behavioral: Dietary sodium reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A LARGE-SCALE CLUSTER RANDOMIZED TRIAL TO DETERMINE THE EFFECTS OF SODIUM REDUCTION ON STROKE: THE CHINA SALT SUBSTITUTE AND STROKE STUDY (SSaSS)

Resource links provided by NLM:


Further study details as provided by The George Institute:

Primary Outcome Measures:
  • Stroke [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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:
  • Total major vascular events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The composite of stroke, acute coronary syndrome or vascular death

  • Total mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Blood Pressure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Urinary sodium excretion [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Urinary Potassium [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Knowledge about sodium and salt substitute [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    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?



Estimated Enrollment: 21000
Study Start Date: March 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT02092090

Contacts
Contact: Nicole Y Li, PhD +61 2 9993 4507 nli@georgeinstitute.org.au
Contact: Bruce C Neal, PhD +61 2 9993 4558 bneal@georgeinstitute.org.au

Locations
China, Liaoning
China Medical Universtity Not yet recruiting
Shenyang, Liaoning, China, 110001
Contact: Jingpu Shi, Master       sjp562013@163.com   
Contact: Bo Zhou, PhD       13709826820@126.com   
Principal Investigator: Jingpu Shi, Master         
Sponsors and Collaborators
The George Institute
Peking University
Northwestern University
Imperial College London
China Medical University, China
Changzhi Medical College
Hebei Province Centre for Disease Control and Prevention
Ningxia Medical University
Xi’an Jiaotong University College of Medicine
Investigators
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

No publications provided

Responsible Party: The George Institute
ClinicalTrials.gov Identifier: NCT02092090     History of Changes
Other Study ID Numbers: SSaSS, Grant ID 1049417
Study First Received: March 12, 2014
Last Updated: March 17, 2014
Health Authority: Australia: National Health and Medical and Research Council
Australia: Human Research Ethics Committee, The University of Sydney
China: Peking University Biomedical Research Ethics Committee

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

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 27, 2014