Hypokalemia
Conditions
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.
Interventions
DRUGHydrochlorothiazide
Hydrochlorothiazide 25 mg a day for 14 days.
DIETARY_SUPPLEMENTLicorice
Licorice candy 32 grams a day for 14 days.
Sponsors
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Potassium | Baseline and 2 weeks | Plasma potassium measured with indirect ion specific electrode method |
Countries
Finland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Region of Enrollment Finland | 10 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Plasma Potassium
Plasma potassium measured with indirect ion specific electrode method
Time frame: Baseline and 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Licorice | Plasma Potassium | Baseline | 4.0 mmol/l | Standard Deviation 0.2 |
| Licorice | Plasma Potassium | 2 weeks | 4.1 mmol/l | Standard Deviation 0.3 |
| Licorice and HCTZ | Plasma Potassium | Baseline | 4.0 mmol/l | Standard Deviation 0.3 |
| Licorice and HCTZ | Plasma Potassium | 2 weeks | 3.7 mmol/l | Standard Deviation 0.2 |
Comparison: Statistical analysis applies to the change in the plasma potassium (baseline to 2 weeks) between armsp-value: 0.007t-test, 2 sided