Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment

This study has been completed.

Sponsor:

Information provided by:

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT00975078

First received: September 7, 2009

Last updated: August 8, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 7, 2009

Last Updated Date

August 8, 2011

Start Date ^ICMJE

May 2009

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary outcome of this study is the rate of adrenal insufficiency assessed on the 7th day after stopping a 14-days course of corticosteroid therapy with 0.5mg/kg KG prednisone per day. [ Time Frame: 7th day after stopping prednisone intake ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00975078 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment

Official Title ^ICMJE

Dexamethasone-suppression-test Predicts Later Development of Adrenal Insufficiency After a 14 Days' Course of Prednisone in Healthy Volunteers

Brief Summary

Suppression of the adrenal function is a common, potentially dangerous and unpredictable consequence of short term high dose glucocorticoid treatment. Identification of patients at risk would be of high clinical importance. The investigators hypothesized that the dexamethasone-suppression-test predicts the subsequent development of corticosteroid induced adrenal insufficiency.

Detailed Description

The objective of this study is to evaluate if adrenal axis integrity investigated by the dexamethasone-suppression-test will predict the development of adrenal insufficiency after 14 days treatment with 0.5mg/kg of body weight prednisone in healthy volunteers. The investigators hypothesize that subjects with a more suppressed cortisol level after dexamethasone will be more likely to develop adrenal insufficiency after 14 days intake of prednisone o.5mg/kg/body weight than subjects with less suppression of their cortisol levels after dexamethasone.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Adrenal Gland Hypofunction

Intervention ^ICMJE

Procedure: adrenal insufficiency testing
On the day getting the baseline data we will perform a low dose cosyntropin test to asses adrenal axis function.

All participants will then undergo an overnight 0.5mg dexamethasone suppression test. Thereby participants will take 0.5mg of dexamethasone at 11 pm and a fasting blood sample will be collected the next morning at 8 am to measure the serum cortisol level.

Six days later participants will start taking 0.5mg/kg body-weight prednisone each morning for 14 days.

On day 1, 3, 7 and 21 after withdrawal of prednisone the participant will undergo a low dose cosyntropin test. The investigators will take a blood sample before and 30 minutes after i.v. administration of 1ug of cosyntropin for the measurement of cortisol.
Drug: prednisone
0.5mg/kg body-weight prednisone each morning for 14 days

Study Arm (s)

Experimental: adrenal insufficiency

Interventions:

Procedure: adrenal insufficiency testing
Drug: prednisone

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2009

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy male volunteers over 18 years

Exclusion Criteria:

No informed consent
Intake of any kind of medication
BMI over 30kg/m2
Acute or chronic illnesses

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00975078

Other Study ID Numbers ^ICMJE

DEXA

Has Data Monitoring Committee

Responsible Party

Mirjam Christ-Crain, Endocrinology, University Hospital Basel

Study Sponsor ^ICMJE

University Hospital, Basel, Switzerland

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Mirjam Christ-Crain, Professor

Division of Endocrinology University Hospital Basel

Information Provided By

University Hospital, Basel, Switzerland

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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