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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01271296
• Date of registration: 22/12/2010
• Prospective Registration: No
• Primary sponsor: Haukeland University Hospital
• Public title: Effects and Interactions of Liquorice and Grapefruit on Glucocorticoid Replacement Therapy in Addison's Disease
• Scientific title: Use of Liquorice and Grapefruit in Patients With Addison's Disease
• Date of first enrolment: April 2008
• Target sample size: 17
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01271296
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
• Phase: N/A

Countries of recruitment

Norway

Contacts

• Name: Eystein S Husebye, Prof, MD
• Affiliation: University of Bergen. Helse-Bergen HF.

• Name: Ernst A Lien, Prof. MD.
• Affiliation: University of Bergen

• Name: Paal Methlie, MD
• Affiliation: University of Bergen. Helse-Bergen HF

• Name: Kristian Løvås, MD, PhD
• Affiliation: University of Bergen. Helse-Bergen HF.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Verified diagnosis of adrenal insufficiency (Addison's disease)

- Stable cortisone acetate replacement therapy

- Written informed consent

Exclusion Criteria:

- Malignant disease

- Pharmacological treatment with other glucocorticoids

- Pregnancy

- Current minor disease (ie the flu)

- Major disease or accident requiring hospitalization the last three months

- Use of grapefruit juice or liquorice the last two weeks before study start

- Blood pressure above 150mmHg systolic or 90 mmHg diastolic.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Addison Disease

Intervention(s)

Dietary Supplement: Grapefruit Juice

Dietary Supplement: Liquorice

Primary Outcome(s)

AUC Serum Cortisol - Levels of cortisol in serum during the first 2.6 hours after oral administration of cortisone acetate. [Time Frame: Outcome measures are assessed when all subjects have completed the study, approximately 1.5-2.0 years after study start.]

Secondary Outcome(s)

Time of maximum concentration of Saliva Cortisone [Time Frame: Outcome measures are assessed when all subjects have completed the study, approximately 1.5-2.0 years after study start.]

Time of maximum concentration of serum Cortisone [Time Frame: Outcome measures are assessed when all subjects have completed the study, approximately 1.5-2.0 years after study start.]

Urinary ratio (aTHF+THF)/THE [Time Frame: Outcome measures are assessed when all subjects have completed the study, approximately 1.5-2.0 years after study start.]

Saliva Cortisone levels at the end of time-series sampling (t=160min) [Time Frame: Outcome measures are assessed when all subjects have completed the study, approximately 1.5-2.0 years after study start.]

Half life of serum cortisol [Time Frame: Outcome measures are assessed when all subjects have completed the study, approximately 1.5-2.0 years after study start.]

Serum Cortisol levels at the end of time-series sampling (t=160min) [Time Frame: Outcome measures are assessed when all subjects have completed the study, approximately 1.5-2.0 years after study start.]

Urinary Ratio Cortisol/6beta-OH-Cortisol [Time Frame: Outcome measures are assessed when all subjects have completed the study, approximately 1.5-2.0 years after study start.]

AUC Serum Cortisone [Time Frame: Outcome measures are assessed when all subjects have completed the study, approximately 1.5-2.0 years after study start.]

Serum Cortisone levels at the end of time-series sampling (t=160min) [Time Frame: Outcome measures are assessed when all subjects have completed the study, approximately 1.5-2.0 years after study start.]

Time of maximum concentration of Saliva Cortisol [Time Frame: Outcome measures are assessed when all subjects have completed the study, approximately 1.5-2.0 years after study start.]

AUC Saliva Cortisol [Time Frame: Outcome measures are assessed when all subjects have completed the study, approximately 1.5-2.0 years after study start.]

AUC Saliva cortisone [Time Frame: Outcome measures are assessed when all subjects have completed the study, approximately 1.5-2.0 years after study start.]

Urinary aTHF/THF-ratio [Time Frame: Outcome measures are assessed when all subjects have completed the study, approximately 1.5-2.0 years after study start.]

Urine total metabolites (Urinary cortisol+cortisone+6OHF+aTHF+THF+THE) [Time Frame: Outcome measures are assessed when all subjects have completed the study, approximately 1.5-2.0 years after study start.]

Half life of serum cortisone [Time Frame: Outcome measures are assessed when all subjects have completed the study, approximately 1.5-2.0 years after study start.]

Saliva Cortisol levels at the end of time-series sampling (t=160min) [Time Frame: Outcome measures are assessed when all subjects have completed the study, approximately 1.5-2.0 years after study start.]

Time of maximum concentration of serum Cortisol [Time Frame: Outcome measures are assessed when all subjects have completed the study, approximately 1.5-2.0 years after study start.]

Secondary ID(s)

07/5829 (SHdir)

17775 (NSD)

3.2007.2620

3.2007.2620 (REK)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors