A Phase 4 interventional study of Hydrochlorothiazide and Licorice in Hypokalemia, sponsored by University of Oulu. Completed at 1 site in Finland. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-12-15.
Sponsored by University of Oulu · Phase 4, Interventional, and Treatment
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.
26 studies on the registry are indexed under Hypokalemia; 5 are open to participants now.
This study's enrollment of 10 is below the median of 73 across 18 interventional studies indexed under Hypokalemia.
Browse Hypokalemia studies →University of Oulu is the lead sponsor of 138 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary Supplement: Licorice
Drug: Hydrochlorothiazide
Hydrochlorothiazide 25 mg a day for 14 days.
Also known as: Hydrex semi, ATC C03AA03
Licorice candy 32 grams a day for 14 days.
Also known as: Pepe Original candy
Plasma Potassium
Plasma potassium measured with indirect ion specific electrode method
Time frame: Baseline and 2 weeks
| Milestone | Licorice First, Then Licorice and HCTZ | Licorice and HCTZ First, Then Licorice |
|---|---|---|
| Started | 5 | 5 |
| Completed | 5 | 5 |
| Not completed | 0 | 0 |
| Milestone | Licorice First, Then Licorice and HCTZ | Licorice and HCTZ First, Then Licorice |
|---|---|---|
| Started | 5 | 5 |
| Completed | 5 | 5 |
| Not completed | 0 | 0 |
| Milestone | Licorice First, Then Licorice and HCTZ | Licorice and HCTZ First, Then Licorice |
|---|---|---|
| Started | 5 | 5 |
| Completed | 5 | 5 |
| Not completed | 0 | 0 |
Plasma potassium measured with indirect ion specific electrode method
| mmol/l | Licorice | Licorice and HCTZ |
|---|---|---|
| Baseline | 4.0 ± 0.2 | 4.0 ± 0.3 |
| 2 weeks | 4.1 ± 0.3 | 3.7 ± 0.2 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Licorice | — | 0/10 (0%) | 0/10 (0%) |
| Licorice and HCTZ | — | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Entire Study Population |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Entire Study Population |
|---|---|
| Female | 5 |
| Male | 5 |
| Region of Enrollment(participants) | Entire Study Population |
|---|---|
| Finland | 10 |
This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Oulu