HydrocortisoneNCT02403921
Association Between Cortisol, Cortisone, Cotinine, Nicotine, Caffeine, Melatonin Levels in Hair, Serum, Urine, Saliva and Chronic Stress
An observational study of Hydrocortisone, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The investigators aim to investigate the association between hair, serum, urine and saliva to measure cortisol, cortisone, cotinine, nicotine, melatonin and caffeine. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydrocortisone
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2015to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: adult volunteer
Who may be able to join
- adult volunteer
Who cannot join
- students of the study host
- people who have steroid or melatonin medicine
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Test1, Test2, test3
Pau-Chung CHEN, (02)33668088, pchen@ntu.edu.tw
About this study
The investigators aim to investigate the association between hair, serum, urine and saliva to measure cortisol, cortisone, cotinine, nicotine, melatonin and caffeine.
- Conditions
- Hydrocortisone
- Keywords
- biomarker
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese Health Questionnaire (CHQ)
Measured: 5 minutes
Hospital Anxiety and Depression Scale (HADS)
Measured: 5 minutes
Pittsburgh Sleep Quality Index (PSQI)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocortisoneStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pau-Chung CHEN, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403921
- Sponsor's protocol ID
- 201412205RINA
- Status last verified
- Mar 2015
- First submitted
- 26 Mar 2015
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Cortisol, Cortisone, Cotinine, Nicotine, Caffeine, Melatonin Levels in Hair, Serum, Urine, Saliva and Chronic Stress
- ClinicalTrials.gov ID
- NCT02403921
- Acronym / sponsor ID
- 201412205RINA
- Conditions
- Hydrocortisone
- Keywords
- biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to investigate the association between hair, serum, urine and saliva to measure cortisol, cortisone, cotinine, nicotine, melatonin and caffeine.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- adult volunteer
Key inclusion criteria (1 listed)
- adult volunteer
Key exclusion criteria (2 listed)
- students of the study host
- people who have steroid or melatonin medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chinese Health Questionnaire (CHQ)
Time frame: 5 minutes
Hospital Anxiety and Depression Scale (HADS)
Time frame: 5 minutes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pau-Chung CHEN principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocortisone, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pau-Chung CHEN ((02)33668088, pchen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese Health Questionnaire (CHQ) (time frame: 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.