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Effect of Licorice and Hydrochlorothiazide on Plasma Potassium

NCT ID: NCT00605202

Last Updated: 2009-12-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypokalemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Licorice

Group Type ACTIVE_COMPARATOR

Licorice

Intervention Type DIETARY_SUPPLEMENT

Licorice candy 32 grams a day for 14 days.

Licorice and HCTZ

Group Type ACTIVE_COMPARATOR

Hydrochlorothiazide

Intervention Type DRUG

Hydrochlorothiazide 25 mg a day for 14 days.

Interventions

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Hydrochlorothiazide

Hydrochlorothiazide 25 mg a day for 14 days.

Intervention Type DRUG

Licorice

Licorice candy 32 grams a day for 14 days.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Hydrex semi, ATC C03AA03 Pepe Original candy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Oulu University Hospital

Principal Investigators

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Markku Savolainen, MD

Role: PRINCIPAL_INVESTIGATOR

Oulu University Hospital

Locations

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Oulu University Hospital

Oulu, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type RESULT
PMID: 19562574 (View on PubMed)

Other Identifiers

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Lakritsi ja hypokalemia

Identifier Type: -

Identifier Source: org_study_id