Hashimoto DiseaseNCT01102205
Evaluation of Oxidative Stress and Effect of Levothyroxine Treatment on Oxidative Stress in Hashimoto Disease
An observational study of Hashimoto Disease, run by Vakif Gureba Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Oxidative stress leads to or accompanies with numerous disease. Oxidative balance in subclinical hypothyroid or euthyroid state in Hashimoto disease are not known. Effect of levothyroxine therapy on oxidative balance are also not known in hashimoto disease. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Hashimoto Disease
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2010to Oct 2010
- 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 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: adult with Hashimoto disease in euthyroid or subclinical hypothyroid state and healthy control.
Who may be able to join
- age more than 18 years
Who cannot join
- inability to give a written consent
- other conditions and drug usage affect oxidative stress
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Vakif Gureba Training and Research Hospital
Istanbul, 34100
About this study
Oxidative stress leads to or accompanies with numerous disease. Oxidative balance in subclinical hypothyroid or euthyroid state in Hashimoto disease are not known. Effect of levothyroxine therapy on oxidative balance are also not known in hashimoto disease.
Read the detailed description
oxidative stress markers will be measured initially(TAS,TOS,OSI,PARAOXONASE,ARYLESTERASA,PON1 PHENOTYPİNG,LİPİDPEROXİD).After 3 months therapy with levothyroxine measurements will be repeated except PON1 phenotyping.
- Conditions
- Hashimoto Disease
- Medical subject headings
- Hashimoto Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy | Not described | |
| euthyroid hashimoto | Not described | |
| hypothyroid hashimoto | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Poxidative stress markers
Measured: After levotren therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hashimoto DiseaseStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vakif Gureba Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ali Cikrikcioglu, Vakif Gureba Training and Research Hospital
- Investigators
- Mehmet ali Cikrikcioglu, MD, Study chair, vakif gureba TRH,fatih,istanbul,turkey.specialist in internal medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102205
- Sponsor's protocol ID
- tastoshashi
- Status last verified
- Jun 2013
- First submitted
- 9 Apr 2010
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oxidative Stress and Effect of Levothyroxine Treatment on Oxidative Stress in Hashimoto Disease
- ClinicalTrials.gov ID
- NCT01102205
- Acronym / sponsor ID
- tastoshashi
- Conditions
- Hashimoto Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Vakif Gureba Training and Research HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 13 Apr 2010 (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.
Oxidative stress leads to or accompanies with numerous disease. Oxidative balance in subclinical hypothyroid or euthyroid state in Hashimoto disease are not known. Effect of levothyroxine therapy on oxidative balance are also not known in hashimoto disease.
Detailed description
oxidative stress markers will be measured initially(TAS,TOS,OSI,PARAOXONASE,ARYLESTERASA,PON1 PHENOTYPİNG,LİPİDPEROXİD).After 3 months therapy with levothyroxine measurements will be repeated except PON1 phenotyping.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy | – | – |
| euthyroid hashimoto | – | – |
| hypothyroid hashimoto | – | – |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adult with Hashimoto disease in euthyroid or subclinical hypothyroid state and healthy control.
Key inclusion criteria (1 listed)
- age more than 18 years
Key exclusion criteria (2 listed)
- inability to give a written consent
- other conditions and drug usage affect oxidative stress
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
Poxidative stress markers
Time frame: After levotren therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2013.
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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.
Mehmet ali Cikrikcioglu, MD study chair
vakif gureba TRH,fatih,istanbul,turkey.specialist in internal medicine
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 Hashimoto Disease, run by Vakif Gureba Training and Research Hospital at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 13 Jun 2013. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Poxidative stress markers (time frame: After levotren therapy). 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 13 Jun 2013.