NIPH Clinical Trials Search

A study to see how salt reduction advice at pharmacies in Mie Prefecture affects blood pressure and salt sensitivity in people with chronic kidney disease

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Chronic kidney disease
Date of first enrollment	01/11/2025
Target sample size	100
Countries of recruitment
Study type	Interventional
Intervention(s)	1 . Brief nutritional counseling using an informational leaflet on salt reduction. 2. Confirmation and recording of resting home blood pressure (as recorded in a blood pressure diary or equivalent) for the 7 days prior to the date of consent (Day 1). 3. Collection of patients baseline information. 4. Salt sensitivity testing using Salsave. 5. Questionnaire survey regarding awareness of salt-reduction counseling.

Outcome(s)

Primary Outcome

The mean systolic blood pressure measured during the 7 days prior to the intervention and during the 7 days following the intervention, based on home blood pressure recordings.

Secondary Outcome

1. Salt sensitivity assessed using Salsave: Mean value across six taste concentration levels (0.6%, 0.8%, 1.0%, 1.2%, 1.4%, and 1.6%). 2. Patient awareness survey regarding salt reduction. 3. Renal function (eGFR). 4. Serum creatinine level and blood urea nitrogen/creatinine ratio. 5. Serum Na Cl difference (as an index of metabolic acidosis). 6. Analysis of factors influencing the success of salt reduction.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender
Include criteria	1) Disease and Diagnostic Criteria: Patients with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m^2. 2) Disease Stage and Type: Patients classified as having CKD stage G3a or higher according to the CKD severity classification. 3) Age: 18 years or older. 4) Home Blood Pressure Monitoring: Patients capable of consistently recording their blood pressure upon awakening (or in the morning) at home using a blood pressure diary or an equivalent record. 5) General Condition: Not specified. 6) Relevant Major Organ Function: Kidney function. 7) Informed Consent: Written informed consent from the patient is required.
Exclude criteria	1) Inability to record home blood pressure upon awakening (or in the morning) using a blood pressure diary or an equivalent record. 2) Inability to continuously visit a participating community pharmacy for a period of three months. 3) Difficulty in communication or impaired ability to communicate. 4) Undergoing maintenance dialysis. 5) Morning (or early morning) blood pressure below 90/60 mmHg, or experiencing dizziness due to hypotension. 6) Oral salt intake as a prescribed medication. 7) Addition or dose escalation of antihypertensive medication between the intervention start date and the end of the observation period. 8) Determined to be inappropriate for participation in this study by the principal investigator or sub-investigators.