Effect of Licorice and Hydrochlorothiazide on Plasma Potassium

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2009

Interventions

  • Drug: Hydrochlorothiazide
    • Hydrochlorothiazide 25 mg a day for 14 days.
  • Dietary Supplement: Licorice
    • Licorice candy 32 grams a day for 14 days.

Arms, Groups and Cohorts

  • Active Comparator: Licorice
  • Active Comparator: Licorice and HCTZ

Clinical Trial Outcome Measures

Primary Measures

  • Plasma Potassium
    • Time Frame: Baseline and 2 weeks
    • Plasma potassium measured with indirect ion specific electrode method

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Oulu
  • Provider of Information About this Clinical Study
    • Professor Markku Savolainen, Oulu University Hospital
  • Overall Official(s)
    • Markku Savolainen, MD, Principal Investigator, Oulu University Hospital

Citations Reporting on Results

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.

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