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Effect of Licorice and Hydrochlorothiazide on Plasma Potassium

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00605202
First Posted: January 30, 2008
Last Update Posted: December 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Oulu
  Purpose
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.

Condition Intervention Phase
Hypokalemia Drug: Hydrochlorothiazide Dietary Supplement: Licorice Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Licorice and Hydrochlorothiazide on Plasma Potassium

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Plasma Potassium [ Time Frame: Baseline and 2 weeks ]

Enrollment: 10
Study Start Date: February 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Licorice Dietary Supplement: Licorice
Licorice candy 32 grams a day for 14 days.
Other Name: Pepe Original candy
Active Comparator: Licorice and HCTZ Drug: Hydrochlorothiazide
Hydrochlorothiazide 25 mg a day for 14 days.
Other Name: Hydrex semi, ATC C03AA03

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00605202


Locations
Finland
Oulu University Hospital
Oulu, Finland, 90220
Sponsors and Collaborators
University of Oulu
Investigators
Principal Investigator: Markku Savolainen, MD Oulu University Hospital
  More Information

Publications:
Responsible Party: Professor Markku Savolainen, Oulu University Hospital
ClinicalTrials.gov Identifier: NCT00605202     History of Changes
Other Study ID Numbers: Lakritsi ja hypokalemia
First Submitted: January 17, 2008
First Posted: January 30, 2008
Results First Submitted: August 13, 2009
Results First Posted: December 9, 2009
Last Update Posted: December 15, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Hypokalemia
Potassium Deficiency
Water-Electrolyte Imbalance
Metabolic Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hydrochlorothiazide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action