An interventional study of Dietary sodium reduction in Stroke, sponsored by The George Institute. Completed at 5 sites in China. Per ClinicalTrials.gov, last updated 2021-04-08.
Sponsored by The George Institute · Not applicable, Interventional, and Prevention
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.
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.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 20,996 is above the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →The George Institute is the lead sponsor of 56 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Dietary advice at baseline only
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
Also known as: Reduced-sodium added-potassium salt substitute
Stroke
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.
Time frame: 5 years
Total major vascular events
The composite of stroke, acute coronary syndrome or vascular death
Time frame: 5 years
Total mortality
Time frame: 5 years
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
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?
Time frame: 5 years
Ran from Jul 2014 to primary completion in Sep 2020, 73 months.
Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 73 months is above that.
Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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