Dietary potassium liberalization with fruit and vegetables versus potassium restriction in people with chronic kidney disease (DK-Lib CKD): a clinical trial protocol.


Journal

BMC nephrology
ISSN: 1471-2369
Titre abrégé: BMC Nephrol
Pays: England
ID NLM: 100967793

Informations de publication

Date de publication:
13 10 2023
Historique:
received: 26 07 2023
accepted: 27 09 2023
medline: 2 11 2023
pubmed: 14 10 2023
entrez: 13 10 2023
Statut: epublish

Résumé

Potassium regulation in the body is primarily done in the kidney. In addition to this, hyperkalemia, occurs in approximately 10% of individuals with chronic kidney disease (CKD) and is associated with elevated all-cause mortality. Individuals with CKD are often told to restrict dietary potassium (K), however, this recommendation is based on low quality evidence. Reduced quality of life, limited dietary choices and nutritional deficiencies are all potential negative outcomes that may occur when restricting dietary K in CKD patients. There is a need for randomized controlled trials investigating the impact of dietary K modification on serum K concentrations in people with CKD. A randomized 2-period crossover design comparing a liberalized K fruit and vegetable diet where participants will be required to consume ~ 3500 mg of dietary K daily, to a standard K restricted diet where participants will be required to consume < 2000 mg of dietary K daily. All participants will begin on a liberalized K run-in period for 2 weeks where they will receive fruit and vegetables home deliveries and for safety will have clinical chemistry, including serum potassium measurements taken after 1 week. Participants will then be randomized into either liberalized K or standard K diet for six weeks and then crossover to the other intervention for another 6 weeks after a 2-week washout period. 30 male and female CKD outpatients, ≥ 18 years of age, who have an estimated glomerular filtration rate (eGFR) between 15 and 45 ml/min/1.73m This trial has received approval from the University of Manitoba Research Ethics board (HS25191 (B2021:104)).

Sections du résumé

BACKGROUND
Potassium regulation in the body is primarily done in the kidney. In addition to this, hyperkalemia, occurs in approximately 10% of individuals with chronic kidney disease (CKD) and is associated with elevated all-cause mortality. Individuals with CKD are often told to restrict dietary potassium (K), however, this recommendation is based on low quality evidence. Reduced quality of life, limited dietary choices and nutritional deficiencies are all potential negative outcomes that may occur when restricting dietary K in CKD patients. There is a need for randomized controlled trials investigating the impact of dietary K modification on serum K concentrations in people with CKD.
METHODS
A randomized 2-period crossover design comparing a liberalized K fruit and vegetable diet where participants will be required to consume ~ 3500 mg of dietary K daily, to a standard K restricted diet where participants will be required to consume < 2000 mg of dietary K daily. All participants will begin on a liberalized K run-in period for 2 weeks where they will receive fruit and vegetables home deliveries and for safety will have clinical chemistry, including serum potassium measurements taken after 1 week. Participants will then be randomized into either liberalized K or standard K diet for six weeks and then crossover to the other intervention for another 6 weeks after a 2-week washout period.
DISCUSSION
30 male and female CKD outpatients, ≥ 18 years of age, who have an estimated glomerular filtration rate (eGFR) between 15 and 45 ml/min/1.73m
TRIAL REGISTRATION
This trial has received approval from the University of Manitoba Research Ethics board (HS25191 (B2021:104)).

Identifiants

pubmed: 37833679
doi: 10.1186/s12882-023-03354-4
pii: 10.1186/s12882-023-03354-4
pmc: PMC10576319
doi:

Substances chimiques

Potassium RWP5GA015D
Potassium, Dietary 0

Banques de données

ClinicalTrials.gov
['NCT05090865']

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

301

Subventions

Organisme : CIHR
ID : 201610FDN-375939-FDN-CDAA-171854
Pays : Canada

Informations de copyright

© 2023. BioMed Central Ltd., part of Springer Nature.

Références

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Auteurs

Yasmin Iman (Y)

Chronic Disease Innovation Centre, Winnipeg, MB, Canada.

Robert Balshaw (R)

Department of Community Health Sciences, University of Manitoba, Max Rady College of Medicine, Winnipeg, MB, Canada.

Mackenzie Alexiuk (M)

Department of Community Health Sciences, University of Manitoba, Max Rady College of Medicine, Winnipeg, MB, Canada.

Jay Hingwala (J)

Department of Internal Medicine, University of Manitoba, Max Rady College of Medicine, Winnipeg, MB, Canada.

Leah Cahill (L)

Department of Medicine, Dalhousie University, Halifax, NS, Canada.

Rebecca Mollard (R)

Chronic Disease Innovation Centre, Winnipeg, MB, Canada.
Faculty of Agriculture and Food Sciences, Department of Food and Human Nutritional Sciences, University of Manitoba, Manitoba, Canada.

Navdeep Tangri (N)

Chronic Disease Innovation Centre, Winnipeg, MB, Canada.
Department of Community Health Sciences, University of Manitoba, Max Rady College of Medicine, Winnipeg, MB, Canada.

Dylan Mackay (D)

Department of Community Health Sciences, University of Manitoba, Max Rady College of Medicine, Winnipeg, MB, Canada. Dylan.Mackay@umanitoba.ca.
Faculty of Agriculture and Food Sciences, Department of Food and Human Nutritional Sciences, University of Manitoba, Manitoba, Canada. Dylan.Mackay@umanitoba.ca.
George and Fay Yee Centre for Healthcare Innovation, Winnipeg, MB, Canada. Dylan.Mackay@umanitoba.ca.

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