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Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease

Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02519894
Enrollment
600
Registered
2015-08-11
Start date
2015-08-31
Completion date
2016-08-31
Last updated
2015-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Declination of Glomerular Infiltration Rate in Chronic Kidney Disease Population

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

Interventions

BEHAVIORALDietary Scanning Calculator

Sponsors

PANTHITA SORNHIRAN
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* CKD stage 3-4 (eGFR 15-59 mL/min/1.73m²) * Microalbuminuria * Any blood pressure level

Exclusion criteria

* Salt - losing conditions * Hyponatremia (Na \< 135 mg/dL) or Hypernatremia (Na \> 145 mg/dL) * Bilateral renal artery stenosis * Severe comorbid disease or life expectancy \<1 year (severe cardiovascular disease, chronic liver disease, severe infection , malignancy) * Immunosuppressant used

Design outcomes

Primary

MeasureTime frame
The declination of glomerular infiltration rateone year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026