Clarifying Optimal Sodium InTake In Cardiovasular and Kidney (COSTICK) Diseases: a study protocol for two randomised controlled trials [version 2; peer review: 2 approved, 1 approved with reservations]
Background: While low sodium intake (<2.3g/day) is recommended for all, there is uncertainty about feasibility and net cardiovascular effects. In COSTICK, we evaluated the effects of a dietary counselling intervention (reduced sodium intake) on intermediate cardiorenal outcomes in patients with (...
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| Format: | Article |
| Language: | English |
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F1000 Research Ltd
2022-02-01
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| Series: | HRB Open Research |
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| Online Access: | https://hrbopenresearch.org/articles/4-14/v2 |
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| author | Alberto Alvarez-Iglesias Claire Kerins Salim Yusuf Roisin Dineen Aoife Nolan Colette Corcoran Suzanne McDermott Andrew Smyth John Ferguson Ritika Ranjan Orlaith Hernon Martin O'Donnell Paula O'Shea Matthew Griffin Michelle Canavan |
| author_facet | Alberto Alvarez-Iglesias Claire Kerins Salim Yusuf Roisin Dineen Aoife Nolan Colette Corcoran Suzanne McDermott Andrew Smyth John Ferguson Ritika Ranjan Orlaith Hernon Martin O'Donnell Paula O'Shea Matthew Griffin Michelle Canavan |
| author_sort | Alberto Alvarez-Iglesias |
| collection | DOAJ |
| description | Background: While low sodium intake (<2.3g/day) is recommended for all, there is uncertainty about feasibility and net cardiovascular effects. In COSTICK, we evaluated the effects of a dietary counselling intervention (reduced sodium intake) on intermediate cardiorenal outcomes in patients with (STICK) and without (COSIP) mild/moderate kidney disease. Methods: This is a protocol for two phase IIb randomised, two-group, parallel, open-label, controlled, single centre trials. Participants were aged >40 years with stable blood pressure, unchanged anti-hypertensive medications, willing to modify diet and provided written informed consent. Participants were excluded for abnormal sodium handling, heart failure, high dose diuretics, immunosuppression, pregnancy/lactation, postural hypotension, cognitive impairment, high or low body mass index (BMI) or inclusion in another trial. STICK participants had estimated glomerular filtration rate (eGFR) 30-60ml/min/1.73m2 and were excluded for acute kidney Injury, rapidly declining eGFR; known glomerular disease or current use of non-steroidal anti-inflammatory drugs. For COSIP, participants were excluded for known kidney or cardiovascular disease. Participants were randomized to usual care only (healthy eating) or an additional sodium lowering intervention (target <100mmol/day) through specific counseling (sodium use in foods, fresh over processed foods, sodium content of foods and eating outside of home). In STICK the primary outcome is change in 24-hour urinary creatinine clearance. In COSIP, the primary outcome is change in five biomarkers (renin, aldosterone, high sensitivity troponin T, pro-B-type natriuretic peptide and C-reactive protein). Our primary report (COSTICK), reports six biomarker outcome measures in the entire population at 2 years follow-up. Discussion: These Phase II trials will explore uncertainty about low sodium intake and cardiovascular and kidney biomarkers, and help determine the feasibility of low sodium intake. Trial results will also provide preliminary information to guide a future definitive clinical trial, if indicated. Trial registration: STICK: ClinicalTrials.gov NCT02738736 (04/04/2016); COSIP: ClinicalTrials.gov NCT02458248 (15/05/2016) |
| first_indexed | 2024-04-11T08:21:33Z |
| format | Article |
| id | doaj.art-9d25b61b5867442d9ad0dcc2019c2b21 |
| institution | Directory Open Access Journal |
| issn | 2515-4826 |
| language | English |
| last_indexed | 2024-04-11T08:21:33Z |
| publishDate | 2022-02-01 |
| publisher | F1000 Research Ltd |
| record_format | Article |
| series | HRB Open Research |
| spelling | doaj.art-9d25b61b5867442d9ad0dcc2019c2b212022-12-22T04:34:57ZengF1000 Research LtdHRB Open Research2515-48262022-02-01414728Clarifying Optimal Sodium InTake In Cardiovasular and Kidney (COSTICK) Diseases: a study protocol for two randomised controlled trials [version 2; peer review: 2 approved, 1 approved with reservations]Alberto Alvarez-Iglesias0Claire Kerins1Salim Yusuf2Roisin Dineen3Aoife Nolan4https://orcid.org/0000-0003-2351-0786Colette Corcoran5https://orcid.org/0000-0002-7690-5776Suzanne McDermott6Andrew Smyth7https://orcid.org/0000-0002-3320-8292John Ferguson8Ritika Ranjan9Orlaith Hernon10https://orcid.org/0000-0002-8712-6583Martin O'Donnell11Paula O'Shea12Matthew Griffin13Michelle Canavan14HRB Clinical Research Facility Galway, National University of Ireland, Galway, Galway, IrelandHRB Clinical Research Facility Galway, National University of Ireland, Galway, Galway, IrelandPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, CanadaHRB Clinical Research Facility Galway, National University of Ireland, Galway, Galway, IrelandHRB Clinical Research Facility Galway, National University of Ireland, Galway, Galway, IrelandHRB Clinical Research Facility Galway, National University of Ireland, Galway, Galway, IrelandHRB Clinical Research Facility Galway, National University of Ireland, Galway, Galway, IrelandHRB Clinical Research Facility Galway, National University of Ireland, Galway, Galway, IrelandHRB Clinical Research Facility Galway, National University of Ireland, Galway, Galway, IrelandHRB Clinical Research Facility Galway, National University of Ireland, Galway, Galway, IrelandHRB Clinical Research Facility Galway, National University of Ireland, Galway, Galway, IrelandHRB Clinical Research Facility Galway, National University of Ireland, Galway, Galway, IrelandDepartment of Clinical Biochemistry, University Hospital Galway, Galway, IrelandHRB Clinical Research Facility Galway, National University of Ireland, Galway, Galway, IrelandHRB Clinical Research Facility Galway, National University of Ireland, Galway, Galway, IrelandBackground: While low sodium intake (<2.3g/day) is recommended for all, there is uncertainty about feasibility and net cardiovascular effects. In COSTICK, we evaluated the effects of a dietary counselling intervention (reduced sodium intake) on intermediate cardiorenal outcomes in patients with (STICK) and without (COSIP) mild/moderate kidney disease. Methods: This is a protocol for two phase IIb randomised, two-group, parallel, open-label, controlled, single centre trials. Participants were aged >40 years with stable blood pressure, unchanged anti-hypertensive medications, willing to modify diet and provided written informed consent. Participants were excluded for abnormal sodium handling, heart failure, high dose diuretics, immunosuppression, pregnancy/lactation, postural hypotension, cognitive impairment, high or low body mass index (BMI) or inclusion in another trial. STICK participants had estimated glomerular filtration rate (eGFR) 30-60ml/min/1.73m2 and were excluded for acute kidney Injury, rapidly declining eGFR; known glomerular disease or current use of non-steroidal anti-inflammatory drugs. For COSIP, participants were excluded for known kidney or cardiovascular disease. Participants were randomized to usual care only (healthy eating) or an additional sodium lowering intervention (target <100mmol/day) through specific counseling (sodium use in foods, fresh over processed foods, sodium content of foods and eating outside of home). In STICK the primary outcome is change in 24-hour urinary creatinine clearance. In COSIP, the primary outcome is change in five biomarkers (renin, aldosterone, high sensitivity troponin T, pro-B-type natriuretic peptide and C-reactive protein). Our primary report (COSTICK), reports six biomarker outcome measures in the entire population at 2 years follow-up. Discussion: These Phase II trials will explore uncertainty about low sodium intake and cardiovascular and kidney biomarkers, and help determine the feasibility of low sodium intake. Trial results will also provide preliminary information to guide a future definitive clinical trial, if indicated. Trial registration: STICK: ClinicalTrials.gov NCT02738736 (04/04/2016); COSIP: ClinicalTrials.gov NCT02458248 (15/05/2016)https://hrbopenresearch.org/articles/4-14/v2Cardiovascular Disease Chronic Kidney Disease Sodium Reduction Renal Insufficiency Biomarkers Clinical Trialeng |
| spellingShingle | Alberto Alvarez-Iglesias Claire Kerins Salim Yusuf Roisin Dineen Aoife Nolan Colette Corcoran Suzanne McDermott Andrew Smyth John Ferguson Ritika Ranjan Orlaith Hernon Martin O'Donnell Paula O'Shea Matthew Griffin Michelle Canavan Clarifying Optimal Sodium InTake In Cardiovasular and Kidney (COSTICK) Diseases: a study protocol for two randomised controlled trials [version 2; peer review: 2 approved, 1 approved with reservations] HRB Open Research Cardiovascular Disease Chronic Kidney Disease Sodium Reduction Renal Insufficiency Biomarkers Clinical Trial eng |
| title | Clarifying Optimal Sodium InTake In Cardiovasular and Kidney (COSTICK) Diseases: a study protocol for two randomised controlled trials [version 2; peer review: 2 approved, 1 approved with reservations] |
| title_full | Clarifying Optimal Sodium InTake In Cardiovasular and Kidney (COSTICK) Diseases: a study protocol for two randomised controlled trials [version 2; peer review: 2 approved, 1 approved with reservations] |
| title_fullStr | Clarifying Optimal Sodium InTake In Cardiovasular and Kidney (COSTICK) Diseases: a study protocol for two randomised controlled trials [version 2; peer review: 2 approved, 1 approved with reservations] |
| title_full_unstemmed | Clarifying Optimal Sodium InTake In Cardiovasular and Kidney (COSTICK) Diseases: a study protocol for two randomised controlled trials [version 2; peer review: 2 approved, 1 approved with reservations] |
| title_short | Clarifying Optimal Sodium InTake In Cardiovasular and Kidney (COSTICK) Diseases: a study protocol for two randomised controlled trials [version 2; peer review: 2 approved, 1 approved with reservations] |
| title_sort | clarifying optimal sodium intake in cardiovasular and kidney costick diseases a study protocol for two randomised controlled trials version 2 peer review 2 approved 1 approved with reservations |
| topic | Cardiovascular Disease Chronic Kidney Disease Sodium Reduction Renal Insufficiency Biomarkers Clinical Trial eng |
| url | https://hrbopenresearch.org/articles/4-14/v2 |
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