Sodium balance study in healthy participants

Accurate estimation of sodium intake with minimal patient burden in healthy participants

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON23937

Enrollment

Registered

2020-10-10

Start date

2020-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Chronic kidney disease

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: • 18-80 years • estimated glomerular filtration rate (eGFR) above 60 ml/min/1.73m2 as measured with the CKD-EPI equation without albuminuria (albumin >30 mg/24h or albumine-creatinine ratio >3 mg/mmol)

Exclusion criteria

Exclusion criteria: • eGFR below 60 ml/min/1.73m2 as measured with the CKD-EPI equation or albuminuria (albumin >30 mg/24h or albumine-creatinine ratio >3 mg/mmol) • office blood pressure > 140/90 mmHg • diabetes mellitus, hypertension, kidney disease, cardiovascular disease • use of antihypertensive medication, antidiabetic medication or systemic glucocorticoids • (history of) restrictive dietary habits • eating disorder • food allergies

Design outcomes

Primary

Measure	Time frame
The difference between measured and estimated dietary sodium, potassium and Na/K ratio intake, using: - a single 24-hour urine collection - repeated spot urine collections	—

Secondary

Measure	Time frame
For the most accurate estimation of dietary sodium, potassium and Na/K ratio intake, we will: - compare the performance of 1, 3, 5 and 7 consecutive 24-hour urine collections - compare the performance of 1, 3, 5 and 7 consecutive spot urine collections - compare the performance of 1, 3, 5 and 7 consecutive spot urine collections with a single and repeated 24-hour urine collection We will compare the performance of dietary sodium, potassium and Na/K ratio intake estimates based on: - morning, daytime, pre-night and combined morning + pre-night spot urine collections - different spot urine equations Define the potential value of the urine Na/K ratio as compared to separate urine sodium and potassium measurements by comparing discrepancies (%) between: - measured and estimated sodium intake - measured and estimated potassium intake - measured and estimated Na/K ratio Investigate the effects of correcting 24-hour sodium and potassium excretion for 24-hour aldosterone and cortisol excretion, by determining: - estimated sodium and potassium intake by correcting 24-hour urine sodium and potassium excretion for 24-hour urine aldosterone and cortisol excretion - discrepancy (%) between measured and estimated sodium and potassium intake with and without correction for 24-hour urine aldosterone and cortisol excretion	—

Measure

Time frame

For the most accurate estimation of dietary sodium, potassium and Na/K ratio intake, we will: - compare the performance of 1, 3, 5 and 7 consecutive 24-hour urine collections - compare the performance of 1, 3, 5 and 7 consecutive spot urine collections - compare the performance of 1, 3, 5 and 7 consecutive spot urine collections with a single and repeated 24-hour urine collection We will compare the performance of dietary sodium, potassium and Na/K ratio intake estimates based on: - morning, daytime, pre-night and combined morning + pre-night spot urine collections - different spot urine equations Define the potential value of the urine Na/K ratio as compared to separate urine sodium and potassium measurements by comparing discrepancies (%) between: - measured and estimated sodium intake - measured and estimated potassium intake - measured and estimated Na/K ratio Investigate the effects of correcting 24-hour sodium and potassium excretion for 24-hour aldosterone and cortisol excretion, by determining: - estimated sodium and potassium intake by correcting 24-hour urine sodium and potassium excretion for 24-hour urine aldosterone and cortisol excretion - discrepancy (%) between measured and estimated sodium and potassium intake with and without correction for 24-hour urine aldosterone and cortisol excretion

—

Contacts

Public ContactRik Olde Engberink

Academisch Medisch Centrum

r.h.oldeengberink@amsterdamumc.nl0205627445

Outcome results