Evaluation of the reliability of blood Cortisol concentration essay using Electro-ChemiLuminescence ImmunoAssay compared to liquid chromatography-tandem-mass spectrometry in patients with ulcerative colitis treated with oral Prednisone
Not Applicable
Completed
- Conditions
- To compare circulating concentrations of Cortisol measured using two different laboratory methods: the ECLIA COBAS assay and the high-specificity LC/MS/MS assay in patients affected by ulcerative colitis, in treatment with oral Prednisone.Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12610000425099
- Lead Sponsor
- Dr. Antonio Balzano
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Both genders, age between 18 and 70 years (both included);
Clinical diagnosis of acute relapse of UC with extension of the disease above the rectum and indication for systemic corticosteroid (CS) treatment;
Continuous treatment with oral Prednisone at a daily dose >= 30 mg for at least the two weeks preceding enrollment
Exclusion Criteria
Ongoing local (enema) or systemic treatment with CS other than Prednisone;
Low compliance to medical treatment;
Presence of other diseases or treatments that are known to interfere with the evaluation of blood Cortisol concentrations as a measure of hypothalamic-pituitary-adrenal axis suppression
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary aim of the study is to compare circulating concentrations of Cortisol measured using two different laboratory methods: the ECLIA COBAS assay and the high-specificity LC/MS/MS assay[Concentration measures will be collected once only upon recruitment into study]
- Secondary Outcome Measures
Name Time Method il[Nil]