Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05784389
Status:
RECRUITING
Last Update Posted:
2023-03-29
First Post:
2023-03-13
Brief Title:
Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5
Sponsor:
Nordsjaellands Hospital
Organization:
Nordsjaellands Hospital
Study Overview
Official Title:
Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5
Status:
RECRUITING
Status Verified Date:
2023-03
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:
This clinical trial aims to investigate and test the effect of an acidbase diet in chronic kidney disease CKD patients CKD stage 4 and 5 The trial is guided by the hypothesis that an acidbase diet will reduce the degree of acidosis and simultaneously reduce the need for 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 Therefore we aim to investigate this association through an interventional study design
Participants will be asked to follow a restricted diet with a low PRAL during a 6-week trial divided into three periods two-week of free-living control two-weeks of intervention and a two-week free-living follow-up
The PRAL calculation tool will be used to create a diet low in acid and to develop individualized diet plans for each patient The diet will comply with Danish national guidelines on threshold for potassium and protein due to the high risk of hyperkalemia in CKD patients 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 into three periods two-week of free-living control two-weeks of intervention and a two-week free-living follow-up
The PRAL calculation tool will be used to create a diet low in acid and to develop individualized diet plans for each patient The diet will comply with Danish national guidelines on threshold for potassium and protein due to the high risk of hyperkalemia in CKD patients 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