Effect of Licorice and Hydrochlorothiazide on Plasma Potassium
Information source: University of Oulu
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypokalemia
Intervention: Hydrochlorothiazide (Drug); Licorice (Dietary Supplement)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Oulu Official(s) and/or principal investigator(s):
Markku Savolainen, MD, Principal Investigator, Affiliation: Oulu University Hospital
Overall contact:
Marketta Niiranen, Email: marketta.niiranen@ppshp.fi
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: Treatment, Randomized, Open Label, Crossover Assignment, Safety Study
Primary outcome: Change in plasma potassium
Secondary outcome: Change in plasma renin activityChange in serum aldosterone
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
Marketta Niiranen, Email: marketta.niiranen@ppshp.fi
Oulu University Hospital, Oulu 90220, Finland; Recruiting
Markku Savolainen, MD, PhD, Principal Investigator
Additional Information
Starting date: February 2008
Last updated: June 16, 2008
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