Effect of salt reduction instruction on salt sensitivity

JRCT ID: jRCT1042240064

Registered date:30/07/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Chronic kidney disease
• Date of first enrollment: 30/07/2024
• Target sample size: 18
• Countries of recruitment: non,Japan
• Study type: Interventional
• Intervention(s): The starting date of salt reduction instruction at the insurance pharmacy shall be Day 1 and shall continue until Day 84. The salt reduction instruction is given at each visit to the insurance pharmacy using the instruction form. The instruction takes approximately 5 minutes, and the number of times it is given is not specified.

Outcome(s)

• Primary Outcome: Salt sensitivity with Solseve before and after intervention: mean of 6 levels of Solseve taste index 0.6%, 0.8%, 1.0%, 1.2%, 1.4%, and 1.6%.

Secondary Outcome

1. salt sensitivity by SolSave : percentage of improvement of 0.2% or more of 6 levels of SolSave taste index 0.6%, 0.8%, 1.0%, 1.2%, 1.4%, and 1.6%.
2. estimated salt intake calculated from urine at any time
3. average blood pressure upon waking (or in the morning) during the week
4. survey of patients' attitudes toward salt reduction
5. eGFR
6. urinary protein
7. variation in serum Na concentration
8. variation of serum K concentration
9. variation of hemoglobin level

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

) Disease name and diagnosis: Patients with eGFR less than 60 mL/min/1.73 m2.
2) Stage and type of disease: CKD severity classification G3a or higher
3) Age: 18 years and older
4) Indicators of systemic status: any
5) Relevant major organ function: kidney
6) Documented patient consent: required

Exclude criteria

1) Inability to continuously record blood pressure at home upon waking (or in the morning)
2) Unable to visit the insurance pharmacy of the collaborating institution for 3 months
3) Difficulty in communication
4) Patient is on maintenance dialysis
5) Receives medication on a refill prescription
6) Waking (or morning) blood pressure below 90/60 mmHg or dizziness due to low blood pressure
7) Taking salt as a prescription medication
8) Persons who are considered by the principal investigator or research associate to be inappropriate to participate in this study.

Related Information

• Primary Sponsor: Murata Tomohiro
• Source(s) of Monetary Support: Kakenhi (Grants-in-Aid for Scientific Research)