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| Name | Class |
|---|---|
| Health Research Board, Ireland | OTHER |
| National University of Ireland, Galway, Ireland | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Reduction | Experimental | 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). |
|
| Usual care | No Intervention | For all participants, standard care will be provided at the nephrology clinic at GUH or by local general practitioners, and includes treatment of hypertension, underlying comorbidities and optimizing the metabolic profile. Participants randomized to usual care will also attend a dietitian-developed healthy eating guidance session but will not receive specific recommendations targeting sodium intake. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Reduction | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour urinary creatinine clearance from baseline to final follow-up, measured from 24-hour urinary collection and corresponding serum creatinine measurement at randomisation and final visit. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in eGFR (MDRD formula) from baseline to final follow-up | 24 months | |
| Change in eGFR (CKD-EPI formula) from baseline to final follow-up | 24 months | |
| Rates of requirement for renal replacement therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin J O'Donnell, MB PhD MRCPI | National University of Ireland, Galway | Principal Investigator |
| Andrew Smyth, MB PhD | National University of Ireland, Galway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HRB Clinical Research Facility Galway | Galway | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37064508 | Derived | Smyth A, Judge C, Kerins C, McDermott S, Niland A, Corcoran C, Dineen R, Alvarez-Iglesias A, Nolan A, Mente A, Griffin MD, O'Shea P, Canavan M, Yusuf S, O'Donnell M. Dietary counselling to reduce moderate sodium intake: effects on cardiovascular and renal biomarkers: primary findings of the COSIP and STICK phase II feasibility randomised controlled trials. EClinicalMedicine. 2023 Feb 15;57:101856. doi: 10.1016/j.eclinm.2023.101856. eCollection 2023 Mar. | |
| 36348660 |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| 24 months |
| Change in 24-hour urinary protein from baseline to final visit | 24 months |
| Increase in risk category for prognosis of CKD as measured by the KDIGO 2012 CKD classification table | 24 months |
| Change in 24-hour urinary sodium excretion from baseline to final visit | 24 months |
| Change in mean systolic and diastolic blood pressure from 24-hour ambulatory blood pressure monitoring completed at baseline and final visit | 24 months |
| Composite outcome of change in risk category for prognosis of CKD (increase in risk), requirement for renal replacement therapy or death as measured by the KDIGO 2012 CKD classification table | 24 months |
| Change in functional status as measured by the assessment functional status questionnaire | 24 months |
| Derived |
| Smyth A, Yusuf S, Kerins C, Corcoran C, Dineen R, Alvarez-Iglesias A, Ferguson J, McDermott S, Hernon O, Ranjan R, Nolan A, Griffin M, O'Shea P, Canavan M, O'Donnell M. Clarifying Optimal Sodium InTake In Cardiovasular and Kidney (COSTICK) Diseases: a study protocol for two randomised controlled trials. HRB Open Res. 2022 Feb 7;4:14. doi: 10.12688/hrbopenres.13210.2. eCollection 2021. |
| 34164803 | Derived | McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3. |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |