Back to resultsEffect of Licorice and Hydrochlorothiazide on Plasma Potassium
Primary Purpose
Hypokalemia
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Hydrochlorothiazide
Licorice
Sponsored by
About this trial
This is an interventional treatment trial for Hypokalemia
Eligibility 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
Sites / Locations
- Oulu University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Licorice
Licorice and HCTZ
Arm Description
Outcomes
Primary Outcome Measures
Plasma Potassium
Plasma potassium measured with indirect ion specific electrode method
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00605202
Brief Title
Effect of Licorice and Hydrochlorothiazide on Plasma Potassium
Official Title
Effect of Licorice and Hydrochlorothiazide on Plasma Potassium
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Oulu
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypokalemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Licorice
Arm Type
Active Comparator
Arm Title
Licorice and HCTZ
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Hydrochlorothiazide
Other Intervention Name(s)
Hydrex semi, ATC C03AA03
Intervention Description
Hydrochlorothiazide 25 mg a day for 14 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Licorice
Other Intervention Name(s)
Pepe Original candy
Intervention Description
Licorice candy 32 grams a day for 14 days.
Primary Outcome Measure Information:
Title
Plasma Potassium
Description
Plasma potassium measured with indirect ion specific electrode method
Time Frame
Baseline and 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markku Savolainen, MD
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90220
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
19562574
Citation
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.
Results Reference
result
Learn more about this trial
Effect of Licorice and Hydrochlorothiazide on Plasma Potassium
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