Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
2490 participants
INTERVENTIONAL
2022-11-14
2023-06-30
Brief Summary
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Detailed Description
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In one of these trials, conducted in rural Indian hypertensive patients, the use of a salt substitute of 75% sodium chloride and 25% potassium chloride showed a significant reduction of systolic blood pressure with a mean difference of -4.58 mmHg in 3 months from baseline to the end of the trial.
Recently, a large cluster-randomized trial conducted in 600 villages in rural areas of five provinces of China (SSaSS trial) among patients with a history of stroke or 60 years of age or elder with elevated blood pressure showed that stroke rates, major cardiovascular events and death from any cause were significantly lower with a salt substitute than with regular salt. The salt substitute used in this trial had 1/3 less sodium than regular salt and substantially more potassium. Therefore, the salt substitute led to an 8% less sodium intake but a 50% higher intake in potassium. This suggests that the greatest impact of salt substitution in this RCT may have been due to an increase in potassium intake rather than the modest decrease in sodium intake that was associated with an average reduction of 2.65 mmHg for SBP (-4.32 to -0.97) and +0.30 mmHg (-0.72 to +1.32) for DBP. In addition, the mean sodium intake in the studied population in this trial was approximately 4.2 gr/d, which is higher than the global average worldwide sodium consumption of 3.9 gr/d. In contrast, potassium intake was lower than the average global potassium intake. Therefore, several considerations that limit the applicability to other populations remain unresolved. The sodium intake of the Chinese rural population is higher than in many other countries, while the potassium intake is relatively low. In addition, in many countries commercially available foods may have added sodium chloride for preservation and thus increase the amount of sodium to the diet. Therefore, the use of salt substitutes would not fully account for salt intake in most cases. Finally, Chinese social and environmental features may be somewhat different to most western countries.
EPIC's investigators stated the hypothesis that salt substitutes could lower systolic blood pressure in a dose-response mode. Therefore, they propose to conduct a randomized cluster trial to evaluate the effect of consuming two doses enriched potassium salt substitutes preparations compared to regular salt intake on systolic blood pressure in individuals from Rosario department.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Control
regular salt (99% sodium chloride)
No interventions assigned to this group
Salt substitute 1
Salt substitute 1 is a potassium-enriched salt substitute composed of 66% potassium chloride and 33% sodium chloride
Salt substitute 66%33%
Salt substitute composed of 66% potassium chloride and 33% sodium chloride
Salt substitute 2
Salt substitute 2 is a potassium-enriched salt substitute composed of 33% potassium chloride and 66% sodium chloride
Salt substitute 33%/66%
Salt substitute composed of 33% potassium chloride and 66% sodium chloride
Interventions
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Salt substitute 66%33%
Salt substitute composed of 66% potassium chloride and 33% sodium chloride
Salt substitute 33%/66%
Salt substitute composed of 33% potassium chloride and 66% sodium chloride
Eligibility Criteria
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Inclusion Criteria
* The household must be composed of at least 2 individuals
* At least 1 of the individuals included must be over 40 years of age
* The household must be located in Rosario department, Santa Fe province, Argentina
Exclusion Criteria
* use of a potassium-sparing diuretic
* use of a potassium supplement
* known history of hyperkalemia
* use of salt reduced in sodium and enriched in potassium by medical indication
* do not consume any type of salt for medical indication
* known primary or secondary hyperaldosteronism
* known severe kidney disease (routine biochemical measurement of kidney function will not be performed in household members not included in the study).
* Pregnancy or lactation
* Evidence of hyperkalemia and/or a creatinine clearance (calculated through the CKD-EPI formula \<30 ml/min/1.73m2) in baseline blood laboratory. For those participants who consent to be tested, blood sample will be used. For those participant who has a laboratory test performed with those biomarkers in the past 6 months those results will be considered
* Households in which any of the study participants consume more than 50% of their meals prepared outside their home will also be excluded.
18 Years
90 Years
ALL
Yes
Sponsors
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Population Health Research Institute
OTHER
Estudios Clínicos Latino América
OTHER
Responsible Party
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Principal Investigators
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María Luz Diaz, MD
Role: PRINCIPAL_INVESTIGATOR
ECLA- Estudios Clínicos Latino América
Locations
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IIC-Instituto de Investigaciones Clínicas
Rosario, Santa Fe Province, Argentina
Countries
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Central Contacts
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Other Identifiers
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EPIC. Version 2.0
Identifier Type: -
Identifier Source: org_study_id