Project titel: Oral potassium supplementation in healthy men - interactions with the
renin-angiotensin-aldosterone system and the sympathetic nervous system Protocol number:
KARAASS-1 EudraCT number: 2013-004460-66
Introduction The global burden of hypertension is huge. This project focuses on the role of
potassium in human blood pressure regulation. A potassium rich diet lowers blood pressure and
some studies have shown an increase in blood pressure during potassium depletion. Thus an
inverse correlation between potassium intake and blood pressure exists. In this trial the
objective is to test how an oral potassium supplementation, administered in form of the drug
Kaleorid®, interacts with the renin-angiotensin-aldosterone system and the sympathetic
nervous system.
Methods This is a randomized clinical placebo-controlled double-blinded crossover trial. A
group of healthy men will be randomized to either 4 weeks treatment with the drug Kaleorid®,
750mg, 3 tablets 3 times daily or to 4 weeks treatment with placebo.
On day 26 in the first treatment period the participants meet at the hospital to start a
24-hours ambulatory blood pressure and collect a 48-hours urine sample. The same day a blood
sample, an electrocardiogram (ECG) and a fat biopsy from the gluteal region will be done. The
fat biopsy is expected to contain resistance vessels, which are to be investigated further in
the laboratory.
On day 28 in the first treatment period the participants meet at the hospital again and are
tested with an intravenous Angiotensin II infusion followed by continuous measurement of
blood pressure and the following aldosterone response (using blood samples). Blood pressure
will be measured with Finger Plethysmography and vascular tonus will be evaluated with the
use of Impedance Cardiography, Finger Plethysmography and Doppler Ultrasound measurements of
blood flow before, during and after the Angiotensin II infusion.
After this first period of treatment and testing a "washout" period of two weeks is inserted.
After "washout", the participants crossover and starts the second treatment period.
Feasibility All necessary authorities have approved the trial and all cooperation is
established.