Effect of Licorice and Hydrochlorothiazide on Plasma Potassium - Full Text View

Sponsored by:	University of Oulu
Information provided by:	University of Oulu
ClinicalTrials.gov Identifier:	NCT00605202

Purpose

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.

Condition	Intervention	Phase
Hypokalemia	Drug: Hydrochlorothiazide Dietary Supplement: Licorice	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Safety Study
Official Title:	Effect of Licorice and Hydrochlorothiazide on Plasma Potassium

Resource links provided by NLM:

Drug Information available for: Hydrochlorothiazide

U.S. FDA Resources

Further study details as provided by University of Oulu:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	10
Study Start Date:	February 2008
Estimated Study Completion Date:	September 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Licorice: Active Comparator	Dietary Supplement: Licorice Licorice candy 32 grams a day for 14 days.
Licorice and HCTZ: Active Comparator	Drug: Hydrochlorothiazide Hydrochlorothiazide 25 mg a day for 14 days.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605202

Locations

Finland
Oulu University Hospital
Oulu, Finland, 90220

Sponsors and Collaborators

University of Oulu

Investigators

Principal Investigator:

Markku Savolainen, MD

Oulu University Hospital

More Information

No publications provided

Responsible Party:	Oulu University Hospital ( Professor Markku Savolainen )
Study ID Numbers:	Lakritsi ja hypokalemia
Study First Received:	January 17, 2008
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00605202 History of Changes
Health Authority:	Finland: National Agency for Medicines

Study placed in the following topic categories:

Metabolic Diseases
Sodium Chloride Symporter Inhibitors
Diuretics
Hypokalemia
Water-Electrolyte Imbalance

Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide
Metabolic Disorder
Licorice

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Cardiovascular Agents
Antihypertensive Agents

Hydrochlorothiazide
Pharmacologic Actions
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Hypokalemia
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on September 10, 2009