Effect of Licorice and Hydrochlorothiazide on Plasma Potassium - Tabular View

Tracking Information

First Received Date ^ICMJE

January 17, 2008

Last Updated Date

May 6, 2009

Start Date ^ICMJE

February 2008

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in plasma potassium [ Time Frame: At the start of the arm, 1 week, 2 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00605202 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in plasma renin activity [ Time Frame: At the start of the arm, 1 week, 2 weeks ] [ Designated as safety issue: No ]
Change in serum aldosterone [ Time Frame: At the start of the arm, 1 week, 2 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Change in plasma renin activity [ Time Frame: At the start of the arm, 1 week, 2 weeks. ] [ Designated as safety issue: No ]
Change in serum aldosterone [ Time Frame: At the start of the arm, 1 week, 2 weeks. ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^ICMJE

Effect of Licorice and Hydrochlorothiazide on Plasma Potassium

Official Title ^ICMJE

Effect of Licorice and Hydrochlorothiazide on Plasma Potassium

Brief Summary

This clinical trial is designed to study the effect of the combination of licorice and hydrochlorothiazide on plasma potassium levels in volunteers. In one arm, 10 healthy volunteers will be given 32 grams of licorice a day together with a 25 mg dose of daily hydrochlorothiazide for 14 days. This combination is compared with 32 grams of licorice a day for 14 days given in the other arm. The study is a randomized, open-label cross-over trial. There is at least a 3-week wash-out between the arms. The hypothesis is that the combination of licorice and hydrochlorothiazide will cause hypokalemia. The main outcome measure is the change in the plasma level of potassium between the arms.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Crossover Assignment, Safety Study

Condition ^ICMJE

Hypokalemia

Intervention ^ICMJE

Drug: Hydrochlorothiazide
Dietary Supplement: Licorice

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

September 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy volunteer
Age 18-40 years

Exclusion Criteria:

Any continuous medication
Any significant disease
Hypotension or hypertension
Allergy to licorice or hydrochlorothiazide
Pregnancy and breast feeding
Fear of needles and previous difficult blood samplings
Substance abuse
Participation in another clinical drug trial within 1 month of enrollment

Gender

Both

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland

Administrative Information

NCT ID ^ICMJE

NCT00605202

Responsible Party

Professor Markku Savolainen, Oulu University Hospital

Study ID Numbers ^ICMJE

Lakritsi ja hypokalemia

Study Sponsor ^ICMJE

University of Oulu

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Markku Savolainen, MD

Oulu University Hospital

Information Provided By

University of Oulu

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP