The Effect of Liquorice on Plasma Potassium

This study has been terminated.
(When 9 subjects of targeted 12 subjects had been studied, no changes in plasma potassium were detected and it was deemed futile to continue with enrolment.)
Sponsor:
Information provided by:
University of Oulu
ClinicalTrials.gov Identifier:
NCT00927017
First received: June 22, 2009
Last updated: April 6, 2010
Last verified: April 2010
  Purpose

The hypothesis is that liquorice lowers plasma potassium. This study aims to elucidate the dose-response of this effect with two doses of liquorice (66 grams or 102 grams) per day for two weeks.


Condition Intervention
Healthy
Other: Liquorice 66 g/day
Other: Liquorice 102 g/day

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Lakritsin Vaikutus Kaliumpitoisuuteen

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Change in plasma potassium [ Time Frame: 1 week, 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: June 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Liquorice 66 g/day
Liquorice given 66 grams per day for two weeks
Other: Liquorice 66 g/day
Liquorice 66 g/day for two weeks
Other Name: Pepe Original liquorice
Active Comparator: Liquorice 102 g/day
Liquorice given 102 grams per day for two weeks
Other: Liquorice 102 g/day
Liquorice 102 g/day for two weeks
Other Name: Pepe Original liquorice

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers
  • age 18-40

Exclusion Criteria:

  • any continuous medication
  • hypertension or hypotension
  • allergy to liquorice
  • pregnancy or lactation
  • difficult venipuncture
  • drug or alcohol abuse
  • participation in pharmaceutical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927017

Locations
Finland
Oulu University Hospital
Oulu, Finland, 90220
Sponsors and Collaborators
University of Oulu
Investigators
Principal Investigator: Janne Hukkanen, MD, PhD Oulu University Hospital, Department of Internal Medicine
  More Information

No publications provided

Responsible Party: Janne Hukkanen, Oulu University Hospital, Department of Internal Medicine
ClinicalTrials.gov Identifier: NCT00927017     History of Changes
Other Study ID Numbers: Lakritsi-2
Study First Received: June 22, 2009
Last Updated: April 6, 2010
Health Authority: Finland: Ethics Committee

Keywords provided by University of Oulu:
Healthy volunteers

ClinicalTrials.gov processed this record on July 28, 2014