- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02738736
Clarifying Optimal Sodium Intake Project (COSIP-1)
April 27, 2021 updated by: Dr Andrew Smyth, University College Hospital Galway
Clarifying Optimal Sodium Intake Project- Objective 1
Hypertension is a leading risk factor for cardiovascular disease (CVD) globally, accounting for 25-35% of the population-attributable fraction.
Sodium (salt) intake is a key determinant of blood pressure, and reducing sodium intake has emerged as an important target for population-based interventions to prevent CVD.
However, there is considerable uncertainty about the optimal level of sodium intake that is associated with lowest CV risk, and whether optimal levels differ for different populations and individuals.
International and national guidelines recommend low sodium intake (<2.3g/day, or lower) in all persons, and advocate a population-wide approach to reducing sodium.
Most of the world's population (~95%) consume between 3 and 6g/day of sodium (mean intake 4.0g/day), which means that most people will require a major change to their diet, to achieve the guideline target (<2g/day).
While there is convincing evidence that high sodium intake (>5g/day) is associated with an increased risk of CVD, compared to low or moderate intake, the evidence that low sodium intake (<2.0g/day) is associated with a lower risk of CVD than moderate intake (2.0-5g/day) is inconsistent and inconclusive.
The investigators plan to conduct a Phase IIb clinical trial to evaluate the role of low sodium intake (versus moderate) on cardiovascular biomarkers.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
269
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Galway, Ireland
- HRB Clinical Research Facility Galway
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 40 years or older
- Systolic blood pressure <160mmHg and diastolic blood pressure <95mmHg on three office blood pressure readings at time of screening and confirmed by a study ABPM before randomization of <150/90mmHg
- No change in anti-hypertensive or diuretic medications (including dose) for 3 months before screening visit
- Consumption of moderate sodium intake at screening, defined as an estimated daily sodium intake of >2.3/day estimated from food frequency questionnaire (FFQ)
- Self-reported willingness to modify dietary intake over sustained period, and adhere with directed recommendations over 2 years.
- Signed written informed consent
Exclusion Criteria:
- Known chronic kidney disease (CKD) or most recent eGFR ≤60ml/min/1.73m2
- Participants who are ineligible for COSIP based on their eGFR will be approached about entering the ongoing Sodium Intake in Chronic Kidney Disease (STICK) trial.
Previous cardiovascular disease:
- Myocardial infarction
- Previous percutaneous coronary intervention (PCI) or percutaneous transluminal coronary angioplasty (PTCA)
- Stroke (previous transient ischaemic attack [TIA] is not an exclusion criterion)
Medical diagnosis known to be associated with abnormal renal sodium excretion, including the following:
- Bartter syndrome
- SIADH
- Diabetes insipidus
- Serum sodium <125mmol
- Severe heart failure defined as NYHA Class III/IV OR left ventricular ejection fraction (LVEF) ≤30%
- High-dose loop or thiazide diuretic therapy, exceeding a total daily dose of frusemide 80mg, bumetanide 2mg, hydrochlorothiazide 50mg, bendroflumethiazide 2.5mg, indapamide 2.5mg, metolazone 2.5mg or the use of both a loop and thiazide diuretic
- Unable to follow educational advice of the research team
- Prescribed high-salt diet, low-salt diet or sodium bicarbonate
- Symptomatic postural hypotension or receiving treatment for postural hypotension
- Current or recent use (within one month) of immunosuppressive medications including tacrolimus, cyclosporine, azathioprine or mycophenolate mofetil
- Pregnancy or lactation
- Unable to comply with 24-hour urinary collections, or medical condition making collection of 24-hour urinary collection difficult (e.g. severe urinary incontinence)
- Participant unlikely to comply with study procedures or follow-up visits due to severe comorbid illness or other factor (e.g. inability to travel for follow-up visits, drug or alcohol misuse) in the opinion of the research team
- Cognitive impairment defined as a known diagnosis of dementia or inability to provide informed consent due to cognitive impairment in the opinion of the investigator
- Body Mass Index (BMI) <20 kg/m2 or BMI>40 kg/m2
- Participating in another clinical trial or previous allocation in this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Sodium Reduction
In addition to usual care, those randomised to the intervention arm will receive specific counseling on behavioural and environmental factors that promote sodium reduction after randomization and at all post-randomisation visits, targeting sodium intake of <100mmol/day (<2.3g/day).
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In addition to usual care, those randomised to the intervention arm will receive specific counseling on behavioural and environmental factors that promote sodium reduction after randomization and at all specified post-randomisation visits, targeting sodium intake of <100mmol/day (<2.3g/day).
A research dietitian will develop the specific components of the intervention, based on standardised approaches to education interventions
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No Intervention: Usual Care
Participants randomized to usual care will also attend a dietitian-developed healthy eating guidance session but will not receive specific recommendations targeting sodium intake.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cardiovascular biomarkers (Renin)
Time Frame: 24 months
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Change in renin from baseline to final follow-up, measured from serum measurements taken at randomisation and final visit (T8).
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24 months
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Change in cardiovascular biomarkers (Aldosterone)
Time Frame: 24 months
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Change in aldosterone from baseline to final follow-up, measured from serum measurements taken at randomisation and final visit (T8).
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24 months
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Change in cardiovascular biomarkers (Troponin T)
Time Frame: 24 months
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Change in troponin T from baseline to final follow-up, measured from serum measurements taken at randomisation and final visit (T8).
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24 months
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Change in cardiovascular biomarkers (Pro-BNP)
Time Frame: 24 months
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Change in Pro-BNP from baseline to final follow-up, measured from serum measurements taken at randomisation and final visit (T8).
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24 months
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Change in cardiovascular biomarkers ( C-reactive protein)
Time Frame: 24 months
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Change in C-reactive protein from baseline to final follow-up, measured from serum measurements taken at randomisation and final visit (T8).
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in functional status as measured by the assessment functional status questionnaire
Time Frame: 24 months
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24 months
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Number of cardiovascular events
Time Frame: 24 months
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24 months
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Change in 24-hour urinary sodium excretion
Time Frame: 24 months
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Change in 24-hour urinary sodium excretion from baseline to final visit (two years)
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24 months
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Change in mean systolic and diastolic blood pressure from 24-hour ambulatory blood pressure monitoring
Time Frame: 24 months
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Change in mean systolic and diastolic blood pressure from 24-hour ambulatory blood pressure monitoring completed at baseline and final visit (two years)
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24 months
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Change in eGFR (MDRD formula)
Time Frame: 24 months
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Change in eGFR (MDRD formula) from baseline to final follow-up
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24 months
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Change in eGFR(CKD-EPI formula)
Time Frame: 24 months
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Change in eGFR (CKD-EPI formula) from baseline to final follow-up
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24 months
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Change in RNA measured through PAXgene RNA blood samples
Time Frame: 24 months
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24 months
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Number of recorded falls, syncope and pre-syncope
Time Frame: 24 months
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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Actual)
August 1, 2020
Study Completion (Actual)
August 1, 2020
Study Registration Dates
First Submitted
April 4, 2016
First Submitted That Met QC Criteria
April 13, 2016
First Posted (Estimate)
April 14, 2016
Study Record Updates
Last Update Posted (Actual)
April 28, 2021
Last Update Submitted That Met QC Criteria
April 27, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRBCRFG-010416
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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