HypothyroidismPhase 4NCT01831869
Effect of L-Thyroxine on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism
A Phase 4 study testing L-thyroxine in people with Hypothyroidism and Thyroid Diseases, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
Subclinical hypothyroidism (SCH) is a common condition affecting 3-10% of the general population, especially in women older than 50 years old. It is controversial whether SCH can lead to increased risks of cardiovascular (CV) disease and whether treatment with L-thyroxine reverses these risks. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypothyroidism, Thyroid Diseases, Endocrine System Diseases
- What is being tested?
- L-thyroxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Apr 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female aged of 18 to 60 years old;
- Diagnosis was subclinical hypothyroidism(elevated serum thyroid-stimulating hormone levels with normal serum free T4 levels measured at least two times with a three-month interval);
- untreated.
Who cannot join
- Pregnancy or lactation women;
- Presence of pituitary/hypothalamic disorders, diabetes mellitus or other endocrinal and metabolic disorders;
- Presence of psychological or physical disabilities,acute infection, cerebrovascular or cardiovascular disease, chronic respiratory disease and other illnesses known to alter lipid metabolism;
- Taking lipid-lowering agents and other drugs that known to influence thyroid function, blood pressure, heart function or bile acids;
- Obviously poor compliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Beneficial Effect of L-Thyroxine Long -Term Replacement on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism: A Prospective Study
Subclinical hypothyroidism (SCH) is a common condition affecting 3-10% of the general population, especially in women older than 50 years old. It is controversial whether SCH can lead to increased risks of cardiovascular (CV) disease and whether treatment with L-thyroxine reverses these risks. The present study was designed to evaluate the effect of L-thyroxine treatment in SCH on lipid profile, atherosclerosis, endothelial function, serum inflammatory factors and adipocytokines.
- Conditions
- Hypothyroidism, Thyroid Diseases, Endocrine System Diseases
- Being tested
- L-thyroxine
- Keywords
- Subclinical hypothyroidism, L-thyroxine, Lipid, endothelial function, inflammatory factor, adipocytokine
- Medical subject headings
- Hypothyroidism, Thyroid Diseases, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-thyroxineDrug
| Study group | Role | What they receive |
|---|---|---|
| L-thyroxine | Active comparator | Oral administration, starting dose 25 or 50 micrograms once daily. Receives: Drug: L-thyroxine |
| blank | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in lipid profile
Measured: measured at baseline; 6 month; 12 months and 24 months.
change in thickness of blood vessel wall
Measured: measured at baseline; 6 months; 12 months and 24 months.
Secondary outcomes (3)
change in endothelial function
Measured: measured at baseline; 6 months; 12 months and 24 months.
change of adipocytokines
Measured: measured at baseline; 6 months; 12 months and 24 months.
Change of Oxidative Stress and Chronic Inflammatory Factors Related with Atherosclerosis
Measured: measured at baseline; 6 months; 12 months and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ling Gao, Shandong Provincial Hospital
- Investigators
- Jiajun Zhao, Study chair, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831869
- Sponsor's protocol ID
- 2012GSF11824
- Status last verified
- Sep 2018
- First submitted
- 7 Apr 2013
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Beneficial Effect of L-Thyroxine Long -Term Replacement on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism: A Prospective Study
- ClinicalTrials.gov ID
- NCT01831869
- Acronym / sponsor ID
- 2012GSF11824
- Conditions
- Hypothyroidism, Thyroid Diseases, Endocrine System Diseases
- Keywords
- Subclinical hypothyroidism, L-thyroxine, Lipid, endothelial function, inflammatory factor, adipocytokine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- Apr 2013
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 15 Apr 2013 (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.
Subclinical hypothyroidism (SCH) is a common condition affecting 3-10% of the general population, especially in women older than 50 years old. It is controversial whether SCH can lead to increased risks of cardiovascular (CV) disease and whether treatment with L-thyroxine reverses these risks. The present study was designed to evaluate the effect of L-thyroxine treatment in SCH on lipid profile, atherosclerosis, endothelial function, serum inflammatory factors and adipocytokines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-thyroxine | Active comparator | Drug: L-thyroxineOral administration, starting dose 25 or 50 micrograms once daily. |
| blank | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and female aged of 18 to 60 years old;
- Diagnosis was subclinical hypothyroidism(elevated serum thyroid-stimulating hormone levels with normal serum free T4 levels measured at least two times with a three-month interval);
- untreated.
Key exclusion criteria (5 listed)
- Pregnancy or lactation women;
- Presence of pituitary/hypothalamic disorders, diabetes mellitus or other endocrinal and metabolic disorders;
- Presence of psychological or physical disabilities,acute infection, cerebrovascular or cardiovascular disease, chronic respiratory disease and other illnesses known to alter lipid metabolism;
- Taking lipid-lowering agents and other drugs that known to influence thyroid function, blood pressure, heart function or bile acids;
- Obviously poor compliance.
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 |
|---|---|---|
| L-thyroxine | Drug | L-thyroxine |
Primary outcome
change in lipid profile
Time frame: measured at baseline; 6 month; 12 months and 24 months.
change in thickness of blood vessel wall
Time frame: measured at baseline; 6 months; 12 months and 24 months.
3 secondary outcomes
change in endothelial function
Time frame: measured at baseline; 6 months; 12 months and 24 months.
change of adipocytokines
Time frame: measured at baseline; 6 months; 12 months and 24 months.
Change of Oxidative Stress and Chronic Inflammatory Factors Related with Atherosclerosis
Time frame: measured at baseline; 6 months; 12 months and 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
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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.
Jiajun Zhao study chair
Shandong Provincial Hospital
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 L-thyroxine in people with Hypothyroidism and Thyroid Diseases, run by Shandong Provincial 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 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 12 Sep 2018. 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?
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?
change in lipid profile (time frame: measured at baseline; 6 month; 12 months and 24 months.). 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 12 Sep 2018.