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Sodium Intake in Chronic Kidney Disease (STICK) (STICK)

Primary Purpose

Kidney Diseases, Renal Insufficiency, Chronic, Renal Insufficiency

Status
Completed
Phase
Phase 2
Locations
Ireland
Study Type
Interventional
Intervention
Sodium Reduction
Sponsored by
University College Hospital Galway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Diseases focused on measuring Chronic Kidney Disease, Sodium Reduction, eGFR 30-60ml/min/1.73m2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HRB Clinical Research Facility Galway

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sodium Reduction

Usual care

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in eGFR (MDRD formula) from baseline to final follow-up
Change in eGFR (CKD-EPI formula) from baseline to final follow-up
Rates of requirement for renal replacement therapy
Change in 24-hour urinary protein from baseline to final visit
Increase in risk category for prognosis of CKD as measured by the KDIGO 2012 CKD classification table
Change in 24-hour urinary sodium excretion from baseline to final visit
Change in mean systolic and diastolic blood pressure from 24-hour ambulatory blood pressure monitoring completed at baseline and final visit
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
Change in functional status as measured by the assessment functional status questionnaire

Full Information

First Posted
May 15, 2015
Last Updated
April 27, 2021
Sponsor
University College Hospital Galway
Collaborators
Health Research Board, Ireland, National University of Ireland, Galway, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT02458248
Brief Title
Sodium Intake in Chronic Kidney Disease (STICK)
Acronym
STICK
Official Title
Sodium Intake in Chronic Kidney Disease (STICK): A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
August 2020 (Actual)
Study Completion Date
August 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Hospital Galway
Collaborators
Health Research Board, Ireland, National University of Ireland, Galway, Ireland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases, Renal Insufficiency, Chronic, Renal Insufficiency
Keywords
Chronic Kidney Disease, Sodium Reduction, eGFR 30-60ml/min/1.73m2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium Reduction
Arm Type
Experimental
Arm Description
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).
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sodium Reduction
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Change in eGFR (MDRD formula) from baseline to final follow-up
Time Frame
24 months
Title
Change in eGFR (CKD-EPI formula) from baseline to final follow-up
Time Frame
24 months
Title
Rates of requirement for renal replacement therapy
Time Frame
24 months
Title
Change in 24-hour urinary protein from baseline to final visit
Time Frame
24 months
Title
Increase in risk category for prognosis of CKD as measured by the KDIGO 2012 CKD classification table
Time Frame
24 months
Title
Change in 24-hour urinary sodium excretion from baseline to final visit
Time Frame
24 months
Title
Change in mean systolic and diastolic blood pressure from 24-hour ambulatory blood pressure monitoring completed at baseline and final visit
Time Frame
24 months
Title
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
Time Frame
24 months
Title
Change in functional status as measured by the assessment functional status questionnaire
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin J O'Donnell, MB PhD MRCPI
Organizational Affiliation
National University of Ireland, Galway
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Smyth, MB PhD
Organizational Affiliation
National University of Ireland, Galway
Official's Role
Principal Investigator
Facility Information:
Facility Name
HRB Clinical Research Facility Galway
City
Galway
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
36348660
Citation
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.
Results Reference
derived
PubMed Identifier
34164803
Citation
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.
Results Reference
derived

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Sodium Intake in Chronic Kidney Disease (STICK)

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