SodiUm Burden Lowered by Lifestyle Intervention: Self-Management and E-health Technology
SUBLIME
3 other identifiers
interventional
99
1 country
4
Brief Summary
The purpose of this study is to evaluate the effects and efficacy of dietary sodium restriction by mean of a new healthcare approach in patients with chronic kidney disease. The test persons in the intervention group are actively supported to adhere to a restricted sodium diet with a structured self-regulation program to implement sodium recommendations that are in current guidelines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2014
CompletedFirst Posted
Study publicly available on registry
May 6, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedMay 13, 2016
May 1, 2016
1.5 years
May 2, 2014
May 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
24-hourly urinary sodium excretion
up to 9 months
Secondary Outcomes (3)
Blood pressure
0, 3, 9 months
Psychological well-being
0, 3, 9 months
Cost-effectiveness
After study closure
Other Outcomes (1)
Tertiary: effect of sodium restriction on cardiorenal biomarkers
0, 3 or 9 months
Study Arms (2)
Intervention SUBLIME
EXPERIMENTALIntervention group
Control
NO INTERVENTIONRegular care
Interventions
Intervention: dietary sodium restriction supported by 2 group meetings, structured self-regulation computer program, e-coaching.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Medical Center Groningenlead
- Dutch Kidney Foundationcollaborator
- Leiden University Medical Centercollaborator
- St. Antonius Hospitalcollaborator
- Ziekenhuisgroep Twentecollaborator
- TNOcollaborator
Study Sites (4)
Ziekenhuisgroep Twente
Almelo, Overijssel, 7609PP, Netherlands
University Medical Center Groningen
Groningen, Provincie Groningen, 9700RB, Netherlands
Leiden University Medical Center
Leiden, South Holland, 2333ZA, Netherlands
St. Antonius
Nieuwegein, Utrecht, 3435CM, Netherlands
Related Publications (2)
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.
PMID: 34164803DERIVEDHumalda JK, Klaassen G, de Vries H, Meuleman Y, Verschuur LC, Straathof EJM, Laverman GD, Bos WJW, van der Boog PJM, Vermeulen KM, Blanson Henkemans OA, Otten W, de Borst MH, van Dijk S, Navis GJ; SUBLIME Investigators. A Self-management Approach for Dietary Sodium Restriction in Patients With CKD: A Randomized Controlled Trial. Am J Kidney Dis. 2020 Jun;75(6):847-856. doi: 10.1053/j.ajkd.2019.10.012. Epub 2020 Jan 16.
PMID: 31955921DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gerjan J Navis, MD PhD
University Medical Center Groningen
- PRINCIPAL INVESTIGATOR
Paul JM Van der Boog, MD PhD
Leiden University Medical Center
- PRINCIPAL INVESTIGATOR
Sandra Van Dijk, PhD
Leiden University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- prof.dr. G.J. Navis
Study Record Dates
First Submitted
May 2, 2014
First Posted
May 6, 2014
Study Start
June 1, 2014
Primary Completion
December 1, 2015
Last Updated
May 13, 2016
Record last verified: 2016-05