Effect of Licorice and Hydrochlorothiazide on Plasma Potassium
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2008
CompletedFirst Posted
Study publicly available on registry
January 30, 2008
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedResults Posted
Study results publicly available
December 9, 2009
CompletedDecember 15, 2009
December 1, 2009
11 months
January 17, 2008
August 13, 2009
December 10, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Plasma Potassium
Plasma potassium measured with indirect ion specific electrode method
Baseline and 2 weeks
Study Arms (2)
Licorice
ACTIVE COMPARATORLicorice and HCTZ
ACTIVE COMPARATORInterventions
Hydrochlorothiazide 25 mg a day for 14 days.
Licorice candy 32 grams a day for 14 days.
Eligibility Criteria
You may qualify if:
- Healthy volunteer
- Age 18-40 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oulu University Hospital
Oulu, 90220, Finland
Related Publications (1)
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;18(4):192-5. doi: 10.1080/08037050903072515.
PMID: 19562574RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Janne Hukkanen
- Organization
- Oulu University Hospital, Department of Internal Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Markku Savolainen, MD
Oulu University Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 17, 2008
First Posted
January 30, 2008
Study Start
February 1, 2008
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
December 15, 2009
Results First Posted
December 9, 2009
Record last verified: 2009-12