QoL Before and After 9 Month of Medical Treatment of Graves´ThyrotoxicosisPhase 2NCT01247077
Neuropsychologic and Immunological Evaluation in Treatment of Thyroid Diseases. Is Selenium Efficient?
A Phase 2 study testing selenium in people with QoL Before and After 9 Month of Medical Treatment of Graves´Thyrotoxicosis and Potential Effect of Selenium, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
Graves thyrotoxicosis is a common autoimmune disease. Patients suffer at diagnosis from weight loss, increased heart rate and stress intolerance. Some patients have difficulties in regaining quality of life. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- QoL Before and After 9 Month of Medical Treatment of Graves´Thyrotoxicosis, Potential Effect of Selenium
- What is being tested?
- selenium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 2 sitesSweden
- Study dates
- Nov 2008to Apr 2014
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- New diagnose of autoimmune thyrotoxicosis
- biochemically proven with increased thyroxin
- low TSH and elevated TRAb/or positive scintigraphy.
- Age 18 - 55. Willing to participate -
Who cannot join
- No previous head trauma,
- No difficulties with swedish language,
- No medication which could affective neuropsychological testing,
- No planned or ongoing pregnancies.
- Normal intellectual capacity.
- No severe ophthalmopathy, or other severe disease
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Jan Calissendorff, Medical clinic, Eskilstuna, Sweden
Eskilstuna, Södermanland County, 63188
Emil Mikulski
Eskilstuna, 63188
About this study
Graves thyrotoxicosis is a common autoimmune disease. Patients suffer at diagnosis from weight loss, increased heart rate and stress intolerance. Some patients have difficulties in regaining quality of life. Diagnosis is found through elevated thyroid hormones thyroxin, suppressed TSH (thyroid stimulating hormone) from the pituitary and elevated stimulatory antibodies, TRAb (thyrotropin receptor antibody) to the thyroid. Selenium is sparse in western Europe. This compound has important function in thyroid hormone metabolism and on the immune system. It is not known whether addition of selenium affects the well being of patients with Graves´thyrotoxicosis. The subject of this study is to investigate this
Read the detailed description
In the County of Södermanland we include 44 patients with Graves´thyrotoxicosis. They are treated with methimazole and thyroxin, and randomised to selenium or placebo. Neuropsychological investigation is performed, before medical treatment is commenced and repeated after 9 month. Serum concentration of thyroid hormon levels, autoantibodies and selenium are followed.
- Conditions
- QoL Before and After 9 Month of Medical Treatment of Graves´Thyrotoxicosis, Potential Effect of Selenium
- Being tested
- selenium, placebo
- Keywords
- selenium, neuropsychological testing, autoantibodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
seleniumOther
200 ug selenium once daily
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| placebo | Active comparator | Placebo and thyroxin + methimazole Receives: Other: placebo |
| selenium | Placebo comparator | selenium + methimazole + thyroxin Receives: Other: selenium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on neuropsychological well-being
Measured: Inclusion going on until the end of 2011
Secondary outcomes (1)
Potential effect on autoantibodies
Measured: Inclusion for the rest of 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startNov 2008
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QoL Before and After 9 Month of Medical Treatment of Graves´ThyrotoxicosisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Calissendorff, MD, Karolinska Institutet
- Investigators
- Jan Calissendorff, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247077
- Sponsor's protocol ID
- DLL-159361
- Status last verified
- Mar 2015
- First submitted
- 23 Nov 2010
- 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
- Neuropsychologic and Immunological Evaluation in Treatment of Thyroid Diseases. Is Selenium Efficient?
- ClinicalTrials.gov ID
- NCT01247077
- Acronym / sponsor ID
- DLL-159361
- Conditions
- QoL Before and After 9 Month of Medical Treatment of Graves´Thyrotoxicosis, Potential Effect of Selenium
- Keywords
- selenium, neuropsychological testing, autoantibodies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 24 Nov 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.
Graves thyrotoxicosis is a common autoimmune disease. Patients suffer at diagnosis from weight loss, increased heart rate and stress intolerance. Some patients have difficulties in regaining quality of life. Diagnosis is found through elevated thyroid hormones thyroxin, suppressed TSH (thyroid stimulating hormone) from the pituitary and elevated stimulatory antibodies, TRAb (thyrotropin receptor antibody) to the thyroid. Selenium is sparse in western Europe. This compound has important function in thyroid hormone metabolism and on the immune system. It is not known whether addition of selenium affects the well being of patients with Graves´thyrotoxicosis. The subject of this study is to investigate this
Detailed description
In the County of Södermanland we include 44 patients with Graves´thyrotoxicosis. They are treated with methimazole and thyroxin, and randomised to selenium or placebo. Neuropsychological investigation is performed, before medical treatment is commenced and repeated after 9 month. Serum concentration of thyroid hormon levels, autoantibodies and selenium are followed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Active comparator | Other: placeboPlacebo and thyroxin + methimazole |
| selenium | Placebo comparator | Other: seleniumselenium + methimazole + thyroxin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- New diagnose of autoimmune thyrotoxicosis
- biochemically proven with increased thyroxin
- low TSH and elevated TRAb/or positive scintigraphy.
- Age 18 - 55. Willing to participate -
Key exclusion criteria (6 listed)
- No previous head trauma,
- No difficulties with swedish language,
- No medication which could affective neuropsychological testing,
- No planned or ongoing pregnancies.
- Normal intellectual capacity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| selenium200 ug selenium once daily | Other | selenium |
| placebo | Other | placebo |
Primary outcome
Effect on neuropsychological well-being
Time frame: Inclusion going on until the end of 2011
1 secondary outcome
Potential effect on autoantibodies
Time frame: Inclusion for the rest of 2011
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 31 Mar 2015.
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.
Jan Calissendorff, MD, PhD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing selenium in people with QoL Before and After 9 Month of Medical Treatment of Graves´Thyrotoxicosis and Potential Effect of Selenium, run by Karolinska Institutet at 2 sites in Sweden.
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 4 inclusion and 6 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 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 2 sites in Sweden. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effect on neuropsychological well-being (time frame: Inclusion going on until the end of 2011). 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.