Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05970094
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2023-07-23
Brief Title:
Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
Official Title:
Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMA-CKD
Brief Summary:
The goal of this clinical trial is to learn about and test the effect of an acidbase diet in chronic kidney patients with CKD stage 4 and 5 in an interventional study with a historical control
The hypothesize is that an acidbase diet will reduce the degree of acidosis and the need for oral bicarbonate supplements
The hypothesize is that an acidbase diet will reduce the degree of acidosis and the need for oral bicarbonate supplements
Detailed Description:
Observational studies indicate that diets with a low potential renal acid load PRAL is associated with a lower serum-bicarbonate value The aim is to investigate this association with an interventional studydesign
Participants will be asked to follow a restricted diet with a low PRAL during a 6 week trial divided in three periodes two week free living control two week intervention and a two week free living follow-up
The PRAL calculation tool will be used to create a diet low in acid based on this the patients will receive individual diet plans The diet will comply with national treshold guidelines for potassium and protein this is due to the high risk of hyperkalemia in patients with chronic kidney disease The patients will be asked to document their food and drink intake by taking pictures of their plates and cups before and after a meal over a 24 hour period
Participants will be asked to follow a restricted diet with a low PRAL during a 6 week trial divided in three periodes two week free living control two week intervention and a two week free living follow-up
The PRAL calculation tool will be used to create a diet low in acid based on this the patients will receive individual diet plans The diet will comply with national treshold guidelines for potassium and protein this is due to the high risk of hyperkalemia in patients with chronic kidney disease The patients will be asked to document their food and drink intake by taking pictures of their plates and cups before and after a meal over a 24 hour period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None