Subclinical HypothyroidismsPhase 4NCT04953195
Thyroid Replacement Therapy in Patients With Subclinical Hypothyroidism
A Phase 4 study testing Levothyroxine Sodium Tablets in people with Subclinical Hypothyroidisms, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
The purpose of this experiment is to compared the changes of thyroid function, anti-thyroid peroxidase antibody, anti-thyroglobulin antibody, thyroid magnetic resonance T1-mapping and various metabolic indexes from baseline to the end of treatment (after the thyroid function had been normal for more than three months) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Subclinical Hypothyroidisms
- What is being tested?
- Levothyroxine Sodium Tablets
- 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
- 1 Jan 2019to 30 Oct 2021
- Phase
- Phase 4
- 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;
- Diagnostic criteria for mild subclinical hypothyroidism :TSH>10mIU/L, thyroxine and free thyroxine levels were normal
- Positive thyroglobulin antibody and/or Thyroperoxidase antibody
- No previous use of drugs affecting thyroid function
Who cannot join
- The contraindications indicated in the Chinese instructions of the drug
- 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
Official title: Effect of Thyroid Replacement Therapy on Thyroid Structure in Patients With Subclinical Hypothyroidism
The purpose of this experiment is to compared the changes of thyroid function, anti-thyroid peroxidase antibody, anti-thyroglobulin antibody, thyroid magnetic resonance T1-mapping and various metabolic indexes from baseline to the end of treatment (after the thyroid function had been normal for more than three months)
Read the detailed description
In patients with autoimmune thyroiditis with mild subclinical hypothyroidism, the study period will include a screening period of not more than 30 days, and a 12-week treatment period compared to baseline. At completion of treatment, Thyroid Stimulating Hormone(TSH), free thyroxine (FT4)，free thyroxine (FT3) will be included. The changes of anti-thyroglobulin antibody, anti-thyroglobulin antibody, T1-mapping and metabolic indexes.
- Conditions
- Subclinical Hypothyroidisms
- Being tested
- Levothyroxine Sodium Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levothyroxine Sodium TabletsDrug
Levothyroxine Sodium(50ug/Tablets,dosage form 25ug,once a day) was administered to patients with autoimmune thyroiditis with mild subclinical hypothyroidism,
| Study group | Role | What they receive |
|---|---|---|
| levothyroxine sodium | Experimental | levothyroxine sodium Receives: Drug: Levothyroxine Sodium Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid Stimulating Hormone changes
Thyroid Stimulating Hormone Changes from baseline and 12 weeks during follow-up
Measured: Thyroid Stimulating Hormone Changes from baseline and 12 weeks during follow-up
free thyroxine changes
free thyroxine changes from baseline and 12 weeks during follow-up
Measured: free thyroxine changes from baseline and 12 weeks during follow-up
T1-mapping values of Thyroid MRI
T1-mapping values of Thyroid MRI Changes from baseline and 12 weeks during follow-up
Measured: T1-mapping values of Thyroid MRI Changes from baseline and 12 weeks during follow-up
Free triiodothyronine changes
Free triiodothyronine changes Changes from baseline and 12 weeks during follow-up
Measured: Free triiodothyronine changes Changes from baseline and 12 weeks during follow-up
Secondary outcomes (2)
anti-thyroid peroxidase antibody changes
anti-thyroid peroxidase antibody changes from baseline and 12 weeks during follow-up
Measured: anti-thyroid peroxidase antibody changes from baseline and 12 weeks during follow-up
anti-thyroglobulin antibody changes
anti-thyroglobulin antibody changes from baseline and 12 weeks during follow-up
Measured: anti-thyroglobulin antibody changes from baseline and 12 weeks 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 posted7 Jul 2021
- Study start1 Jan 2019
- Primary completion15 Sep 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 Subclinical HypothyroidismsStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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, MD, Principal investigator, Beijing Chao-Yang Hospital, Capital Medical University, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953195
- Sponsor's protocol ID
- 2021-309
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2021
- Last updated
- 7 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 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thyroid Replacement Therapy on Thyroid Structure in Patients With Subclinical Hypothyroidism
- ClinicalTrials.gov ID
- NCT04953195
- Acronym / sponsor ID
- 2021-309
- Conditions
- Subclinical Hypothyroidisms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 7 Jul 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.
The purpose of this experiment is to compared the changes of thyroid function, anti-thyroid peroxidase antibody, anti-thyroglobulin antibody, thyroid magnetic resonance T1-mapping and various metabolic indexes from baseline to the end of treatment (after the thyroid function had been normal for more than three months)
Detailed description
In patients with autoimmune thyroiditis with mild subclinical hypothyroidism, the study period will include a screening period of not more than 30 days, and a 12-week treatment period compared to baseline. At completion of treatment, Thyroid Stimulating Hormone(TSH), free thyroxine (FT4)，free thyroxine (FT3) will be included. The changes of anti-thyroglobulin antibody, anti-thyroglobulin antibody, T1-mapping and metabolic indexes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| levothyroxine sodium | Experimental | Drug: Levothyroxine Sodium Tabletslevothyroxine sodium |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women between the ages of 18 and 75;
- Diagnostic criteria for mild subclinical hypothyroidism :TSH>10mIU/L, thyroxine and free thyroxine levels were normal
- Positive thyroglobulin antibody and/or Thyroperoxidase antibody
- No previous use of drugs affecting thyroid function
Key exclusion criteria (5 listed)
- The contraindications indicated in the Chinese instructions of the drug
- Liver function impairment
- Renal function impairment
- Claustrophobia
- Mental disorders
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 |
|---|---|---|
| Levothyroxine Sodium TabletsLevothyroxine Sodium(50ug/Tablets,dosage form 25ug,once a day) was administered to patients with autoimmune thyroiditis with mild subclinical hypothyroidism, | Drug | levothyroxine sodium |
Primary outcome
Thyroid Stimulating Hormone changes
Time frame: Thyroid Stimulating Hormone Changes from baseline and 12 weeks during follow-up
Thyroid Stimulating Hormone Changes from baseline and 12 weeks during follow-up
free thyroxine changes
Time frame: free thyroxine changes from baseline and 12 weeks during follow-up
free thyroxine changes from baseline and 12 weeks during follow-up
T1-mapping values of Thyroid MRI
Time frame: T1-mapping values of Thyroid MRI Changes from baseline and 12 weeks during follow-up
T1-mapping values of Thyroid MRI Changes from baseline and 12 weeks during follow-up
Free triiodothyronine changes
Time frame: Free triiodothyronine changes Changes from baseline and 12 weeks during follow-up
Free triiodothyronine changes Changes from baseline and 12 weeks during follow-up
2 secondary outcomes
anti-thyroid peroxidase antibody changes
Time frame: anti-thyroid peroxidase antibody changes from baseline and 12 weeks during follow-up
anti-thyroglobulin antibody changes
Time frame: anti-thyroglobulin antibody changes from baseline and 12 weeks 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 7 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, MD principal investigator
Beijing Chao-Yang Hospital, Capital Medical University, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levothyroxine Sodium Tablets in people with Subclinical Hypothyroidisms, 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 4 inclusion and 5 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 7 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Thyroid Stimulating Hormone changes (time frame: Thyroid Stimulating Hormone Changes from baseline and 12 weeks during follow-up). The study lists 4 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 7 Jul 2021.