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China Salt Substitute and Stroke Study (SSaSS)

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ClinicalTrials.gov Identifier: NCT02092090
Recruitment Status : Completed
First Posted : March 19, 2014
Last Update Posted : April 8, 2021
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
The George Institute

Tracking Information
First Submitted Date  ICMJE March 12, 2014
First Posted Date  ICMJE March 19, 2014
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE July 9, 2014
Actual Primary Completion Date September 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2014)
  • Total major vascular events [ Time Frame: 5 years ]
    The composite of stroke, acute coronary syndrome or vascular death
  • Total mortality [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 17, 2014)
  • Blood Pressure [ Time Frame: 5 years ]
  • Urinary sodium excretion [ Time Frame: 5 years ]
  • Urinary Potassium [ Time Frame: 5 years ]
  • 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?
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE China Salt Substitute and Stroke Study
Official Title  ICMJE A LARGE-SCALE CLUSTER RANDOMIZED TRIAL TO DETERMINE THE EFFECTS OF SODIUM REDUCTION ON STROKE: THE CHINA SALT SUBSTITUTE AND STROKE STUDY (SSaSS)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Stroke
Intervention  ICMJE 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
Study Arms  ICMJE
  • No Intervention: Control
    Dietary advice at baseline only
  • Experimental: Dietary sodium reduction
    Dietary advice and reduced-sodium added-potassium salt substitute
    Intervention: Behavioral: Dietary sodium reduction
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2021)
20996
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2014)
21000
Actual Study Completion Date  ICMJE September 4, 2020
Actual Primary Completion Date September 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02092090
Other Study ID Numbers  ICMJE SSaSS
Grant ID 1049417 ( Other Grant/Funding Number: Australian National Health and Medical Research Council )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The George Institute
Study Sponsor  ICMJE The George Institute
Collaborators  ICMJE
  • 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
Investigators  ICMJE
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
PRS Account The George Institute
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP