Effect of Licorice and Hydrochlorothiazide on Plasma Potassium

This study has been completed.

Study NCT00605202 Information provided by University of Oulu

First Received on January 17, 2008. Last Updated on December 10, 2009 History of Changes

Results First Received: August 13, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hypokalemia
Interventions:	Drug: Hydrochlorothiazide Dietary Supplement: Licorice

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
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.

Participant Flow for 3 periods

Period 1: First Intervention

	Licorice First, Then Licorice and HCTZ	Licorice and HCTZ First, Then Licorice
STARTED	5	5
COMPLETED	5	5
NOT COMPLETED	0	0

Period 2: Washout Period of 3 Weeks

	Licorice First, Then Licorice and HCTZ	Licorice and HCTZ First, Then Licorice
STARTED	5	5
COMPLETED	5	5
NOT COMPLETED	0	0

Period 3: Second Intervention

	Licorice First, Then Licorice and HCTZ	Licorice and HCTZ First, Then Licorice
STARTED	5	5
COMPLETED	5	5
NOT COMPLETED	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Entire Study Population	No text entered.

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	10
Age [units: participants]
<=18 years	0
Between 18 and 65 years	10
>=65 years	0
Gender [units: participants]
Female	5
Male	5
Region of Enrollment [units: participants]
Finland	10

Outcome Measures

1. Primary:

Plasma Potassium [ Time Frame: Baseline and 2 weeks ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Janne Hukkanen
Organization: Oulu University Hospital, Department of Internal Medicine
phone: +358-8-315 6212
e-mail: janne.hukkanen@oulu.fi

Publications of Results:

Hukkanen J, Ukkola O, Savolainen MJ. Effects of low-dose liquorice alone or in combination with hydrochlorothiazide on the plasma potassium in healthy volunteers. Blood Press. 2009 Jun 26;:1-4 [Epub ahead of print]

Responsible Party:	Professor Markku Savolainen, Oulu University Hospital
ClinicalTrials.gov Identifier:	NCT00605202 History of Changes
Other Study ID Numbers:	Lakritsi ja hypokalemia
Study First Received:	January 17, 2008
Results First Received:	August 13, 2009
Last Updated:	December 10, 2009
Health Authority:	Finland: Finnish Medicines Agency