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Accurate Estimation of Sodium Intake with Limited Patient Burden

Accurate Estimation of Sodium Intake with Limited Patient Burden - Sodium Balance Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54047
Enrollment
40
Registered
2020-09-02
Start date
2021-04-26
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

chronic kidney failure high blood pressure

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy individuals: 18-80 years; eGFR above 60 ml/min/1.73m2 without albuminuria. CKD patients: 18-80 years; eGFR 15-60 and/or albuminuria (albumine >30 mg/24h or albumine-creatinine ratio >3 mg/mmol).

Exclusion criteria

Exclusion criteria: Healthy individuals: albuminuria; BMI > 30 kg/m2; office blood pressure > 140/90 mmHg; history of diabetes mellitus, hypertension, kidney disease, cardiovascular disease, restrictive dietary habits, eating disorders and/or food allergies; use of systemic glucocorticoids, antihypertensive and/or antidiabetic medication. CKD patients: office blood pressure > 180/100 mmHg; suffering of acute kidney injury; changes in antihypertensive medication in the last 2 months; use of systemic glucocorticoids; dialysis treatment or expected initiation of dialysis within 3 months of screening; a history of restrictive dietary habits, an eating disorder or food allergies

Design outcomes

Primary

MeasureTime frame
The main outcome of this study is the difference between measured dietary Na+ and K+ intake and estimated Na+ and K+ intake, using multiple estimation methods. We will compare the abovementioned outcomes in healthy individuals and individuals with chronic kidney disease.

Secondary

MeasureTime frame
We will compare methods for dietary Na+/K+ ratio estimation: single or repeated 24-hour measurement and single or repeated spot urine measurement. We will investigate the potential value of the urine Na+/K+ ratio as compared to separate urine Na+ and K+ measurements. We will investigate the effects of correcting 24-hour Na+ and K+ excretion for 24-hour aldosterone and cortisol excretion. We will compare the abovementioned outcomes in healthy individuals and individuals with chronic kidney disease.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 17, 2026