Effect of Licorice and Hydrochlorothiazide on Plasma Potassium
Information source: University of Oulu
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypokalemia
Intervention: Hydrochlorothiazide (Drug); Licorice (Dietary Supplement)
Phase: Phase 4
Status: Completed
Sponsored by: University of Oulu Official(s) and/or principal investigator(s):
Markku Savolainen, MD, Principal Investigator, Affiliation: Oulu University Hospital
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.
Clinical Details
Official title: Effect of Licorice and Hydrochlorothiazide on Plasma Potassium
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Plasma Potassium
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
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
Locations and Contacts
Oulu University Hospital, Oulu 90220, Finland
Additional Information
Starting date: February 2008
Last updated: December 10, 2009
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