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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06237712
Other study ID # NL84462.078.23
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 26, 2024
Est. completion date July 2026

Study information

Verified date February 2024
Source Erasmus Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

With this research the investigators want to study how patients with chronic kidney disease respond to different sodium- and potassium salts. Potassium salts can prevent kidney damage and cardiovascular disease, however patients with chronic kidney disease can responds differently. Extra potassium can increase the amount of potassium in the blood and extra chloride can cause acidosis. With this study the investigators will gain more insight in how patients with chronic kidney disease respond to sodium and potassium salts and which one is more favorable.This information can then be used to guide the application of salt substitutes and dietary adjustments in patients with chronic kidney disease.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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Locations

Country Name City State
Netherlands ErasmusMC Rotterdam Zuid-Holland

Sponsors (1)

Lead Sponsor Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma bicarbonate by blood draw The absolute difference per treatment group in measured plasma bicarbonate after treatment.
After each treatment of 5 days, plasma bicarbonate will be measured by blood sampling.
The difference between the groups (treatments) will be the main outcome and comparator.
After 5 days of intervention
Secondary Plasma electrolyte levels Na, Cl, K, Mg, Ca, Phosphate (all in mmol/L) After 5 days of intervention
Secondary Urinary citrate Urinary citrate in mmol/24h After 5 days of intervention
Secondary Urinary ammonia urinary ammonia in mmol/24, calculated using the Berthelot method After 5 days of intervention
Secondary Titratable acid Titratable acid = (0.067) × (mLs NaOH (sample titration) - mLs NaOH (blank titration)) × 75/ mLs of sample After 5 days of intervention
Secondary Net acid excretion Net acid excretion unit/24h, formula = sum of the titratable acid and concentration of ammonia minus the concentration of bicarbonate. After 5 days of intervention
Secondary Potential renal acid load PRAL (mEq/d) = 0.49 × protein (g/d) + 0.037 × phosphate (mg/d) - 0.021 × potassium (mg/d) - 0.026 × magnesium (mg/d) - 0.013 × calcium (mg/d). After 5 days of intervention
Secondary Body weight Weight measured by a scale in kilograms After 5 days of intervention
Secondary Blood pressure Systolic and diastolic blood pressure measured 2 times daily during the study, so 20 times during the 5 days of supplement usage. Measurements will be done in the morning and evening measured twice in seated position with an automatic blood pressure monitor. 2 measurements in the morning and evening for 5 days per treatment repeated for 6 treatments in total
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