Please select the eligibility criteria that correspond to the clinical trial below.
Title: Sodium Intake in Chronic Kidney Disease (STICK): A Randomised Controlled Trial
Brief Summary: Chronic kidney disease, which affects an estimated 300,000 people in Ireland and over 50 million people in the developed world, is responsible for a considerable burden of premature mortality and morbidity. All patients with chronic kidney disease are recommended low salt diets, i.e. less than a teaspoon of salt per day (which is \<5-6g of salt, which contains \<2-2.3g of sodium). The average intake in the general population is double the recommended intake, between 1-2 teaspoons per day, which is considered 'moderate' intake. In patients with hypertension, reducing from moderate (average) to low intake is associated with a small reduction in blood pressure. However, achieving this low target salt intake is difficult, and can have a negative knock-on effect on other healthy dietary factors and kidney hormones. In addition, there is no convincing research to show that patients with chronic kidney disease and normal blood pressure benefit from low salt intake. In fact, the small amount of research that does exist shows that the change in kidney function is the same in people who consume low salt diets (\<1 teaspoon) and moderate (1-2 teaspoons=average intake) salt diets. Moreover, there are some small studies that report that low-salt diets may increase the risk of death due to heart disease. Given that all patients with chronic kidney impairment are recommended a low-salt diet, it is important that we confirm that this recommendation truly benefits patients. In this randomized controlled trial, we hope to determine whether recommending a low salt intake, compared to average/moderate intake, is associated with a slower rate of decline in kidney function in patients with chronic kidney impairment. The results of this study will provide information to guide future research that will have critical implications for management of patients with chronic kidney disease.


Options:
A: Inclusion Criteria:

* Be 18 years or older.
* Have chronic kidney disease (CKD stage 1-3, CKD 4 if eGFR is not lower than 25 mL/min/1.73m2, or be a renal transplant recipient.)
* Have a urinary sodium excretion during at least the last 2 subsequent visits of more than 130 mmol per day, or one last urinary sodium excretion of more than 150 mmol per day.
* Have a systolic blood pressure higher than 135 mmHg, diastolic blood pressure higher than 85 mmHg or a well-controlled blood pressure by treatment with antihypertensives including RAAS-blockade (ACE-inhibitor or ARB).
* Sufficient command of the Dutch language.
* Access and ability to use the internet.
* Written informed consent.

Exclusion Criteria:

* eGFR \< 25 ml/min/1.73m2 or an anticipated need for predialysis work-up within the time frame of the study.
* Unstable disease: defined as rapid, persistent, progressive renal function loss (e.g. \> 6 mL/min/1.73m2 per year), not from acute, intermittent origin.
* Blood pressure \> 170 mmHg systolic or \> 100 mmHg diastolic during medical treatment
* Blood pressure \< 95 mmHg systolic not responding to withdrawal of antihypertensives.
* Cardiovascular event (myocardial infarction, cerebrovascular accident) \< 6 months ago.
* Renal transplantation \<1 year ago.
* Medical conditions that are likely to interfere with completion of the study (such as progressive malignancy or other debilitating illness) at the discretion of the nephrologist.
* Every patient who has participated in the ESMO study (regardless whether intervention or control) cannot participate in the current study.
* Current participation in any clinical trial that might interfere with SUBLIME trial.
B: Inclusion Criteria:

* Individuals with end stage renal disease (ESRD) who are 18 years of age or older,
* Individuals who are literate,
* Community-dwelling adults who have been receiving maintenance dialysis for at least 3 months.

Exclusion Criteria:

* Individuals who cannot read or write,
* Individuals who do not speak English,
* Individuals who plan to move out of the area or change dialysis centers within the next 6 months,
* Individuals who have a life expectancy of less than 12 months,
* Individuals who are scheduled for a living donor transplant,
* Individuals who cannot see the PDA screen or use the stylus to make food selections from the PDA screen, or
* Individuals who live in an institutional setting in which they would have limited control over their dietary intake.
C: Inclusion Criteria:

* Age 40 years or older
* MDRD eGFR of 30-60ml/min/1.73m2 on ≥2 occasions ≥3 months apart
* Most recent eGFR measurement within 3 months 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 randomisation 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 \>2.3g/day estimated from food frequency questionnaire (FFQ) completed during the screening visit
* Self-reported willingness to modify dietary intake over sustained period, and adhere to directed recommendations over 2 years
* Signed written informed consent

Exclusion Criteria:

* Acute Kidney Injury in the preceding three months, defined as doubling of baseline serum creatinine or rapidly declining eGFR over the preceding six months, defined as a decline in eGFR of ≥10ml/min/1.73m2 in those with established CKD
* Any of the following renal conditions: glomerular disease due to post-infectious glomerulonephritis, IgA nephropathy, thin basement membrane disease, Henoch-Schonlein purpura, proliferative glomerulonephritis, membranous nephropathy (including lupus nephritis), rapidly progressive glomerulonephritis, minimal change disease, or focal segmental glomerulosclerosis
* Prior or planned renal transplantation
* Prior, current or planned renal dialysis
* Medical diagnosis known to be associated with abnormal renal sodium excretion, including Bartter syndrome, SIADH, diabetes insipidus, or serum sodium \<125mmol
* Severe heart failure (defined as left ventricular ejection fraction ≤30% or NYHA Class III/IV symptoms)
* 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
* Current use of non-steroidal anti-inflammatory drugs (NSAIDs) for 3 or more days per week. Low-dose aspirin \<100mg/day is not an exclusion
* 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 co-morbid illness or other factor (e.g. inability to travel for follow-up visits, drug or alcohol misuse) in opinion of 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) \<20kg/m2 or BMI\>40kg/m2
* Participating in another clinical trial or previous allocation in this study
D: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Diagnosed with CKD and an eGFR ≥ 20 ml/min/1.73m2
* Participant has clinically acceptable laboratory data available to confirm the diagnosis.
* Able (in the opinion of the Investigators) and willing to comply with all study requirements.
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study

Exclusion Criteria:

* Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
* Inability to understand English or special communication needs because the interventions will use English and is not funded to deal with special communication needs.
* Known salt losing nephropathy

Answer: C