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Effect of Licorice and Hydrochlorothiazide on Plasma Potassium

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ClinicalTrials.gov Identifier: NCT00605202
Recruitment Status : Completed
First Posted : January 30, 2008
Results First Posted : December 9, 2009
Last Update Posted : December 15, 2009
Sponsor:
Information provided by:
University of Oulu

January 17, 2008
January 30, 2008
August 13, 2009
December 9, 2009
December 15, 2009
February 2008
January 2009   (Final data collection date for primary outcome measure)
Plasma Potassium [ Time Frame: Baseline and 2 weeks ]
Change in plasma potassium [ Time Frame: At the start of the arm, 1 week, 2 weeks ]
Complete list of historical versions of study NCT00605202 on ClinicalTrials.gov Archive Site
Not Provided
  • Change in plasma renin activity [ Time Frame: At the start of the arm, 1 week, 2 weeks. ]
  • Change in serum aldosterone [ Time Frame: At the start of the arm, 1 week, 2 weeks. ]
Not Provided
Not Provided
 
Effect of Licorice and Hydrochlorothiazide on Plasma Potassium
Effect of Licorice and Hydrochlorothiazide on Plasma Potassium
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypokalemia
  • Drug: Hydrochlorothiazide
    Hydrochlorothiazide 25 mg a day for 14 days.
    Other Name: Hydrex semi, ATC C03AA03
  • Dietary Supplement: Licorice
    Licorice candy 32 grams a day for 14 days.
    Other Name: Pepe Original candy
  • Active Comparator: Licorice
    Intervention: Dietary Supplement: Licorice
  • Active Comparator: Licorice and HCTZ
    Intervention: Drug: Hydrochlorothiazide
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
Same as current
January 2009
January 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT00605202
Lakritsi ja hypokalemia
No
Not Provided
Not Provided
Professor Markku Savolainen, Oulu University Hospital
University of Oulu
Not Provided
Principal Investigator: Markku Savolainen, MD Oulu University Hospital
University of Oulu
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP