Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment
|ClinicalTrials.gov Identifier: NCT00975078|
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : August 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Adrenal Gland Hypofunction||Procedure: adrenal insufficiency testing Drug: prednisone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dexamethasone-suppression-test Predicts Later Development of Adrenal Insufficiency After a 14 Days' Course of Prednisone in Healthy Volunteers|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
|Experimental: adrenal insufficiency||
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.
0.5mg/kg body-weight prednisone each morning for 14 days
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975078
|Division of Endocrinology University Hospital Basel|
|Basel, Switzerland, 4053|
|Principal Investigator:||Mirjam Christ-Crain, Professor||Division of Endocrinology University Hospital Basel|