Thyroid OrbitopathyNCT03891043
Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy
A study testing Selenium in people with Thyroid Orbitopathy, run by Instituto de Oftalmología Fundación Conde de Valenciana.
Trial summary
Background: The activity of thyroid orbitopathy can be evaluated with CAS (Clinical Activity Score) based on 7 inflammatory signs. Selenium acts as an oxide-reducing agent in thioredoxin-reductase, and as an anti-inflammatory agent by reducing the hydroxy peroxide intermediates on the cyclo-oxygenase pathways. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Orbitopathy
- What is being tested?
- Selenium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Apr 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with active mild thyroid orbitopathy according to CAS scale.
- Older than 18 years of age.
Who cannot join
- Patients with mild thyroid orbitopathy undergoing treatment with corticosteroids.
- Active smokers
- Patients allergic to Selenium
- Follow-up shorter than 6 months
About this study
Official title: Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy to Reduce Its
Background: The activity of thyroid orbitopathy can be evaluated with CAS (Clinical Activity Score) based on 7 inflammatory signs. Selenium acts as an oxide-reducing agent in thioredoxin-reductase, and as an anti-inflammatory agent by reducing the hydroxy peroxide intermediates on the cyclo-oxygenase pathways. Increased oxidative stress has been observed in Graves' disease and therefore, by incorporating an antioxidant such as selenium in patients with mild thyroid ophthalmopathy, inflammatory activity could be reduced or inactivated.
General Objective: To determine the clinical differences between patients with mild thyroid orbitopathy who were administered oral supplementation with selenium and patients who were administered oral placebo.
Read the detailed description
This is a simple controlled clinical trial. In which 66 eyes of 33 patients were studied. Fifteen patients were assigned to the placebo group and 18 to the Selenium group. We randomized into two groups the patients with mild clinical activity according to CAS score. Group A took placebo pills twice a day which consisted in 100µg of starch, and Group B took a pill of Selenium 100 µg twice a day. All the subjects tool the pills during six months. Patients of both groups where examined and evaluated with CAS score before and after the first, third and sixth month of treatment.
- Conditions
- Thyroid Orbitopathy
- Being tested
- Selenium, Placebo
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeleniumDietary supplement
A 100 micrograms of Selenium was given to be taken twice a day.
PlaceboOther
Placebo pill of 100 micrograms of starch was given to be taken twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Group A, Placebo group | Placebo comparator | Placebo consisted in a pill of 100 micrograms of starch, to be taken twice a day. Receives: Other: Placebo |
| Group B, Selenium group | Experimental | Selenium consisted in a pill of 100 micrograms, to be taken twice a day. Receives: Dietary Supplement: Selenium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Activity Score (CAS)
Clinical Activity Score (CAS) scale consists of 7 measurements used to evaluate clinical activity of thyroid orbitopathy:
- Spontaneus orbital pain
- Gaze evoked orbital pain
- Conjunctival redness that is considered to be due to active GO
- Eyelid erythema
- Chemosis
- Eyelid swelling that is considered to be due to active GO
- Inflammation of plica or caruncle
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study startAug 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid OrbitopathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891043
- Sponsor's protocol ID
- CI-043-2015
- Status last verified
- Sep 2018
- First submitted
- 15 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy to Reduce Its
- ClinicalTrials.gov ID
- NCT03891043
- Acronym / sponsor ID
- CI-043-2015
- Conditions
- Thyroid Orbitopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 26 Mar 2019 (actual)
- 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.
Background: The activity of thyroid orbitopathy can be evaluated with CAS (Clinical Activity Score) based on 7 inflammatory signs. Selenium acts as an oxide-reducing agent in thioredoxin-reductase, and as an anti-inflammatory agent by reducing the hydroxy peroxide intermediates on the cyclo-oxygenase pathways. Increased oxidative stress has been observed in Graves' disease and therefore, by incorporating an antioxidant such as selenium in patients with mild thyroid ophthalmopathy, inflammatory activity could be reduced or inactivated.
General Objective: To determine the clinical differences between patients with mild thyroid orbitopathy who were administered oral supplementation with selenium and patients who were administered oral placebo.
Detailed description
This is a simple controlled clinical trial. In which 66 eyes of 33 patients were studied. Fifteen patients were assigned to the placebo group and 18 to the Selenium group. We randomized into two groups the patients with mild clinical activity according to CAS score. Group A took placebo pills twice a day which consisted in 100µg of starch, and Group B took a pill of Selenium 100 µg twice a day. All the subjects tool the pills during six months. Patients of both groups where examined and evaluated with CAS score before and after the first, third and sixth month of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A, Placebo group | Placebo comparator | Other: PlaceboPlacebo consisted in a pill of 100 micrograms of starch, to be taken twice a day. |
| Group B, Selenium group | Experimental | Dietary Supplement: SeleniumSelenium consisted in a pill of 100 micrograms, to be taken twice a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with active mild thyroid orbitopathy according to CAS scale.
- Older than 18 years of age.
Key exclusion criteria (4 listed)
- Patients with mild thyroid orbitopathy undergoing treatment with corticosteroids.
- Active smokers
- Patients allergic to Selenium
- Follow-up shorter than 6 months
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 |
|---|---|---|
| SeleniumA 100 micrograms of Selenium was given to be taken twice a day. | Dietary supplement | Group B, Selenium group |
| PlaceboPlacebo pill of 100 micrograms of starch was given to be taken twice a day. | Other | Group A, Placebo group |
Primary outcome
Clinical Activity Score (CAS)
Time frame: 6 months after treatment
Clinical Activity Score (CAS) scale consists of 7 measurements used to evaluate clinical activity of thyroid orbitopathy: 1. Spontaneus orbital pain 2. Gaze evoked orbital pain 3. Conjunctival redness that is considered to be due to active GO 4. Eyelid erythema 5. Chemosis 6. Eyelid swelling that is considered to be due to active GO 7. Inflammation of plica or caruncle
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 26 Mar 2019.
Related trials for Thyroid Orbitopathy
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Not yet recruitingPhase 2
Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) With Atorvastatin (ATORGO)
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Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Selenium in people with Thyroid Orbitopathy, run by Instituto de Oftalmología Fundación Conde de Valenciana.
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 2 inclusion and 4 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 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Clinical Activity Score (CAS) (time frame: 6 months after treatment). 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 26 Mar 2019.