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Effects and Interactions of Liquorice and Grapefruit on Glucocorticoid Replacement Therapy in Addison's Disease

NCT01271296 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2011-01-17

No results posted yet for this study

Summary

Addison's disease is a rare disease, wherein the adrenals can not produce sufficient steroid hormones (cortisol and aldosterone). Patients with Addison's disease report impaired subjective health status, and they have increased all-cause mortality. Conventional therapy is by oral replacement of glucocorticoid and mineralocorticoid hormones, but this strategy imperfectly mimic the diurnal cortisol variations, and render the patients both over- and under-treated. Anecdotally, some patients with adrenal insufficiency may benefit from the use of various nutritional compounds. We hypothesised that liquorice and grapefruit altered the metabolism and absorption of cortisone acetate.

Conditions

  • Addison Disease

Interventions

DIETARY_SUPPLEMENT

Liquorice

24 gram liquorice eq. to 150 mg glycyrrhizinic acid, taken orally, for three days.

DIETARY_SUPPLEMENT

Grapefruit Juice

200 ml pink grapefruit juice three times a day, taken orally, for three days.

Sponsors & Collaborators

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Paal Methlie, MD · University of Bergen. Helse-Bergen HF

  • Kristian Løvås, MD, PhD · University of Bergen. Helse-Bergen HF.

  • Eystein S Husebye, Prof, MD · University of Bergen. Helse-Bergen HF.

  • Ernst A Lien, Prof. MD. · University of Bergen

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01271296 on ClinicalTrials.gov