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Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment

NCT00975078 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2011-08-09

No results posted yet for this study

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.

Conditions

  • Adrenal Gland Hypofunction

Interventions

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

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Mirjam Christ-Crain, Professor · Division of Endocrinology University Hospital Basel

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • Switzerland

Study Locations

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Entities

Drugs

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 NCT00975078 on ClinicalTrials.gov