Sodium balance study in participants with chronic kidney disease

Accurate estimation of sodium intake with minimal patient burden in participants with chronic kidney disease

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON21179

Enrollment

Registered

2020-11-03

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) 15-60 ml/min/1.73m2 as measured with the CKD-EPI equation and/or albuminuria (albumin >30 mg/24h or albumine-creatinine ratio >3 mg/mmol)

Exclusion criteria

Exclusion criteria: • office blood pressure > 180/100 mmHg • 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 • (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 Determine the effects of age, medication use, eGFR and proteinuria on 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 Determine the effects of age, medication use, eGFR and proteinuria on 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