SeleniumNCT04942769
Study on the Effect of Selenium Supplementation on the Structure and Function of Autoimmune Thyroiditis
A study testing Selenium in people with Selenium, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
To evaluate the effects of exogenous selenium supplementation on autoimmune thyroiditis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Selenium
- What is being tested?
- Selenium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2019to 30 Oct 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women between the ages of 18 and 75
- Clinical diagnosis of autoimmune thyroiditis, serum TPOAb and TGAB positive
- Thyroid function is normal, and no drugs affecting thyroid function such as Umetole and Serge have been used
Who cannot join
- The contraindications indicated in the Chinese instructions of the drug
- Hypothyroidism, hyperthyroidism
- Liver function impairment
- Renal function impairment
- Claustrophobia
- Mental disorders
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality
Jia liu, MD, 861085231710, liujia0116@126.com
About this study
To evaluate the effects of exogenous selenium supplementation on autoimmune thyroiditis.
Read the detailed description
In patients with autoimmune thyroiditis， investigators compared changes in thyroid function, anti-thyroid peroxidase antibody, anti-thyroglobulin antibody, thyroid magnetic resonance T1-mapping values and metabolic indicatorsfrom baseline to the end of treatment (12 weeks)
- Conditions
- Selenium
- Being tested
- Selenium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeleniumDrug
selenium 100ug ，take it orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| selenium | Experimental | selenium was administered to patients with autoimmune thyroiditis Receives: Drug: Selenium |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-thyroglobulin antibody changes
Changes from baseline and 3 months during follow-up
Measured: Changes from baseline and 3 months during follow-up
T1-mapping values of Thyroid MRI
Changes from baseline and 3 months during follow-up
Measured: Changes from baseline and 3 months during follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start20 Dec 2019
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeleniumStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- patients with Autoimmune thyroiditis
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Wang, Beijing Chao Yang Hospital
- Investigators
- Guang Wang, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942769
- Sponsor's protocol ID
- 2021-310
- Status last verified
- Jul 2021
- First submitted
- 24 Jun 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Selenium Supplementation on the Structure and Function of Autoimmune Thyroiditis
- ClinicalTrials.gov ID
- NCT04942769
- Acronym / sponsor ID
- 2021-310
- Conditions
- Selenium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 28 Jun 2021 (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.
To evaluate the effects of exogenous selenium supplementation on autoimmune thyroiditis.
Detailed description
In patients with autoimmune thyroiditis， investigators compared changes in thyroid function, anti-thyroid peroxidase antibody, anti-thyroglobulin antibody, thyroid magnetic resonance T1-mapping values and metabolic indicatorsfrom baseline to the end of treatment (12 weeks)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients with Autoimmune thyroiditis
| Arm | Type | Receives |
|---|---|---|
| selenium | Experimental | Drug: Seleniumselenium was administered to patients with autoimmune thyroiditis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women between the ages of 18 and 75
- Clinical diagnosis of autoimmune thyroiditis, serum TPOAb and TGAB positive
- Thyroid function is normal, and no drugs affecting thyroid function such as Umetole and Serge have been used
Key exclusion criteria (6 listed)
- The contraindications indicated in the Chinese instructions of the drug
- Hypothyroidism, hyperthyroidism
- Liver function impairment
- Renal function impairment
- Claustrophobia
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 |
|---|---|---|
| Seleniumselenium 100ug ，take it orally twice daily | Drug | selenium |
Primary outcome
anti-thyroglobulin antibody changes
Time frame: Changes from baseline and 3 months during follow-up
Changes from baseline and 3 months during follow-up
T1-mapping values of Thyroid MRI
Time frame: Changes from baseline and 3 months during follow-up
Changes from baseline and 3 months during follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
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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.
Guang Wang principal investigator
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selenium in people with Selenium, run by Beijing Chao Yang Hospital at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 16 Jul 2021. 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 China. 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 Jia Liu, MD (861085231710, liujia0116@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anti-thyroglobulin antibody changes (time frame: Changes from baseline and 3 months during follow-up). The study lists 2 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 16 Jul 2021.