Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-02-25 @ 6:43 PM
Study NCT ID:
NCT02519894
Status:
UNKNOWN
Last Update Posted:
2015-08-11
First Post:
2015-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease
Sponsor:
PANTHITA SORNHIRAN
Organization:
Study Overview
Official Title:
Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease
Status:
UNKNOWN
Status Verified Date:
2015-08
Last Known Status:
ENROLLING_BY_INVITATION
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:
None
Brief Summary:
Introduction :
Due to Chronic kidney disease is a public health problem, which is important increased in both developed and developing countries . And sodium intake restriction was related to the reduction of blood pressure and urine protein which is one of the important risk factor in chronic kidney disease. One of the problem in sodium restriction failure in Thai population with CKD nowadays is lack of knowledge and problem unawareness.
The study hypothesis :
Intense knowledge about sodium reduction and immediate feedback of the sodium intake could be simultaneously modifying the behavior to reduce sodium intake , blood pressure and also GFR reduction rate
Objectives :
To compare the effect of dietary salt restriction on glomerular filtration rate (GFR) between CKD patients receiving strict controlled combined with immediate individual feedback (DISC Progrram) and those receiving standard education.
Study design :
Multicenter, open labeled, parallel, randomized controlled trial
Sample size : 600
Primary outcome : GFR reduction (CKD-EPI)
Secondary outcome :
* Achievement rate of Na intake \< 2 g/day (Urine Na \< 90 mEq/day)
* Blood pressure difference
* Proportions of patients with BP reached the target (130/80 mmHg)
* Number of anti-hypertensive drugs use to achieve BP target
* Urine albumin/creatinine ratio
* Major Adverse Cardiac Events (MACE)
* Cardio-ankle vascular index (CAVI)
* ankle-brachial index (ABI)
Documentary Proof of Ethical Clearance :
This project has been reviewed and approved by the Comittee on Human Rights Related to Research Involving Human Subjects , based on the declaration of Helsinki
Due to Chronic kidney disease is a public health problem, which is important increased in both developed and developing countries . And sodium intake restriction was related to the reduction of blood pressure and urine protein which is one of the important risk factor in chronic kidney disease. One of the problem in sodium restriction failure in Thai population with CKD nowadays is lack of knowledge and problem unawareness.
The study hypothesis :
Intense knowledge about sodium reduction and immediate feedback of the sodium intake could be simultaneously modifying the behavior to reduce sodium intake , blood pressure and also GFR reduction rate
Objectives :
To compare the effect of dietary salt restriction on glomerular filtration rate (GFR) between CKD patients receiving strict controlled combined with immediate individual feedback (DISC Progrram) and those receiving standard education.
Study design :
Multicenter, open labeled, parallel, randomized controlled trial
Sample size : 600
Primary outcome : GFR reduction (CKD-EPI)
Secondary outcome :
* Achievement rate of Na intake \< 2 g/day (Urine Na \< 90 mEq/day)
* Blood pressure difference
* Proportions of patients with BP reached the target (130/80 mmHg)
* Number of anti-hypertensive drugs use to achieve BP target
* Urine albumin/creatinine ratio
* Major Adverse Cardiac Events (MACE)
* Cardio-ankle vascular index (CAVI)
* ankle-brachial index (ABI)
Documentary Proof of Ethical Clearance :
This project has been reviewed and approved by the Comittee on Human Rights Related to Research Involving Human Subjects , based on the declaration of Helsinki
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: