Oral potassium supplementation in healthy men - interactions with the renin-angiotensin-aldosterone system and the sympathetic nervous system

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004460-66-DK

Enrollment

Registered

2014-03-06

Start date

2014-04-01

Completion date

Unknown

Last updated

2017-01-16

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

Conditions

Blood pressure regulation and hypertension MedDRA version: 16.1 Level: LLT Classification code 10008393 Term: Change in blood pressure System Organ Class: 100000004866 MedDRA version: 16.1 Level: LLT Classification code 10053967 Term: Potassium supplementation System Organ Class: 100000004865

Interventions

Trade Name: Kaleorid, 750mg Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: Potassium chloride Other descriptive name: POTASSIUM CHLORIDE Concentration unit: mg milligram(s) Concent

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Male Age: 20-55 Office Blood pressure: =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Diabetes mellitus Cerebrovascular disease, ischemic heart disease, peripheral artery disease Kidney disease Adrenal disease Ulcers Medical treatment Drug or alcohol abuse Pathological ECG Mental not suitable Hyperkalemia

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is to test whether oral potassium supplementation, administered as Kaleorid, interacts with the renin-angiotensin-aldosterone system and the sympathetic nervous system. ;Secondary Objective: Not applicable;Primary end point(s): Angiotensin II stimulated S-aldosterone;Timepoint(s) of evaluation of this end point: Date: 2017-10-01	—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Date: 2017-10-01;Secondary end point(s): Angiotensin II stimulated blood pressure Angiotensin II stimulated total peripheral resistance (TPR) Angiotensin II stimulated resistance index (RI) in central vessels of the abdomen Level of receptor expression and receptor function in resistance vessels from fat biopsies P-epinephrine and P-norepinephrine Urinary content of epinephrine and norepinephrine Angiotensin II stimulated P-epinephrine and Angiotensin II stimulated P-norepinephrine	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Date: 2017-10-01;Secondary end point(s): Angiotensin II stimulated blood pressure Angiotensin II stimulated total peripheral resistance (TPR) Angiotensin II stimulated resistance index (RI) in central vessels of the abdomen Level of receptor expression and receptor function in resistance vessels from fat biopsies P-epinephrine and P-norepinephrine Urinary content of epinephrine and norepinephrine Angiotensin II stimulated P-epinephrine and Angiotensin II stimulated P-norepinephrine

—

Countries

Denmark

Contacts

Public ContactRasmus Dreier

Rasmus Dreier

rasmus.dreier.01@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026