Clarifying Optimal Sodium Intake Project

• Register: ClinicalTrials.gov
• Last refreshed on: 10 May 2021
• Main ID: NCT02738736
• Date of registration: 04/04/2016
• Prospective Registration: No
• Primary sponsor: University College Hospital Galway
• Public title: Clarifying Optimal Sodium Intake Project COSIP-1
• Scientific title: Clarifying Optimal Sodium Intake Project- Objective 1
• Date of first enrolment: April 2016
• Target sample size: 269
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02738736
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Ireland

Contacts

• Name: Andrew Smyth, MB PhD
• Affiliation: National University of Ireland, Galway

• Name: Martin J O'Donnell, MB PhD MRCPI
• Affiliation: National University of Ireland, Galway

Key inclusion & exclusion criteria

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



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Kidney Disease

Cardiovascular Disease

Blood Pressure

Hypertension

Intervention(s)

Behavioral: Sodium Reduction

Primary Outcome(s)

Change in cardiovascular biomarkers ( C-reactive protein) [Time Frame: 24 months]

Change in cardiovascular biomarkers (Troponin T) [Time Frame: 24 months]

Change in cardiovascular biomarkers (Aldosterone) [Time Frame: 24 months]

Change in cardiovascular biomarkers (Renin) [Time Frame: 24 months]

Change in cardiovascular biomarkers (Pro-BNP) [Time Frame: 24 months]

Secondary Outcome(s)

Change in eGFR(CKD-EPI formula) [Time Frame: 24 months]

Number of cardiovascular events [Time Frame: 24 months]

Change in eGFR (MDRD formula) [Time Frame: 24 months]

Change in 24-hour urinary sodium excretion [Time Frame: 24 months]

Change in RNA measured through PAXgene RNA blood samples [Time Frame: 24 months]

Change in mean systolic and diastolic blood pressure from 24-hour ambulatory blood pressure monitoring [Time Frame: 24 months]

Change in functional status as measured by the assessment functional status questionnaire [Time Frame: 24 months]

Number of recorded falls, syncope and pre-syncope [Time Frame: 24 months]

Secondary ID(s)

HRBCRFG-010416

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National University of Ireland, Galway, Ireland

European Research Council