Trial Outcomes & Findings for Effect of Licorice and Hydrochlorothiazide on Plasma Potassium (NCT NCT00605202)

NCT ID: NCT00605202

Last Updated: 2009-12-15

Results Overview

Plasma potassium measured with indirect ion specific electrode method

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 10 participants
• Primary outcome timeframe: Baseline and 2 weeks
• Results posted on: 2009-12-15

Participant Flow

Participant milestones

Measure	Licorice First, Then Licorice and HCTZ Licorice 32 grams a day in the first intervention period, then licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily in the second intervention period.	Licorice and HCTZ First, Then Licorice Licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily in the first intervention period, then licorice 32 grams a day in the second intervention period.
Second Intervention STARTED	5	5
Second Intervention COMPLETED	5	5
Second Intervention NOT COMPLETED	0	0
First Intervention STARTED	5	5
First Intervention COMPLETED	5	5
First Intervention NOT COMPLETED	0	0
Washout Period of 3 Weeks STARTED	5	5
Washout Period of 3 Weeks COMPLETED	5	5
Washout Period of 3 Weeks NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Licorice and Hydrochlorothiazide on Plasma Potassium

Baseline characteristics by cohort

Measure	Entire Study Population n=10 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment Finland	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 2 weeks

Plasma potassium measured with indirect ion specific electrode method

Outcome measures

Measure	Licorice n=10 Participants	Licorice and HCTZ n=10 Participants
Plasma Potassium 2 weeks	4.1 mmol/l Standard Deviation 0.3	3.7 mmol/l Standard Deviation 0.2
Plasma Potassium Baseline	4.0 mmol/l Standard Deviation 0.2	4.0 mmol/l Standard Deviation 0.3

Adverse Events

Licorice

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Licorice and HCTZ

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Janne Hukkanen

Oulu University Hospital, Department of Internal Medicine

Phone: +358-8-315 6212

Email: janne.hukkanen@oulu.fi

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place