Hashimoto ThyroiditisNCT05871957
Adjuvant Therapeutic Effect of Vitamin D on Hashimoto's Thyroiditis
An observational study of Hashimoto Thyroiditis, run by Qianfoshan Hospital.
Trial summary
The purpose of this study is to explore the relationship between vitamin D and Hashimoto's thyroiditis and to explore whether vitamin D can play an adjuvant role in the treatment of Hashimoto's thyroiditis. Epidemiological surveys show that vitamin D deficiency rates are as high as 50%-90% in HT patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Hashimoto Thyroiditis
- What is being tested?
- Vitamin D Drops
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 30 Sep 2023
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult
Study population: Hashimoto's thyroiditis patients with hypothyroidism.
Who may be able to join
- Meeting the diagnostic criteria of Hashimoto's thyroiditis in Western medicine (according to the Chinese Guidelines for the Diagnosis and Treatment of Thyroid Diseases - Thyroiditis and the Guidelines for the Diagnosis and Treatment of hypothyroidism in adults).
- Signing informed consent.
Who cannot join
- Patients with thyroid cancer;
- Other thyroid related diseases, such as Graves' disease;
- History of thyroid surgery or radioiodine therapy;
- Life history of iodine deficiency area with goiter;
- Immunosuppressive agents or immunomodulatory agents (mannan peptide, ubenamex, cyclophosphamide, incense) should be used within 1 month Polysaccharide, interferon, glucocorticoid, etc.); Other proprietary Chinese medicine (Bailing capsule, Prunella capsule, etc.)
- Patients taking chronic medications that may interfere with thyroid hormone or vitamin D metabolism;
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- pregnancy plan during pregnancy or within six months;
- Severe liver and renal dysfunction;
- Serious systemic diseases, such as heart failure, stroke, and malignant tumors;
- With other autoimmune diseases: type 1 diabetes mellitus, systemic lupus erythematosus, rheumatoid arthritis, Vitiligo, autoimmune adrenal dysfunction;
- Those who are supplementing other trace elements;
- People allergic to vitamin D;
- Patients with hypercalcemia or other related diseases or mental disorders are unwilling to cooperate.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to explore the relationship between vitamin D and Hashimoto's thyroiditis and to explore whether vitamin D can play an adjuvant role in the treatment of Hashimoto's thyroiditis. Epidemiological surveys show that vitamin D deficiency rates are as high as 50%-90% in HT patients. Dietary supplementation with vitamin D has been evaluated as a way to protect the thyroid gland from autoimmune damage, but the results of randomized clinical trials are unclear.
Read the detailed description
Hashimoto's thyroiditis (HT), also known as chronic lymphocytic or autoimmune thyroiditis (AITD), is a type of chronic autoimmune thyroid disease that is associated with varying degrees of hypothyroidism, thyroid autoantibody production, and lymphocytic infiltration. In China, the incidence rate showed a rising trend year by year. For the majority of HT hypothyroidism patients, synthetic levothyroxine (LT4) (first crystallized by Kendall in 1915, commercialized in the 1930s, and mass-produced in the 1960s) remains the only effective drug for HT patients. The treatment works for most patients, but is still controversial. Dietary vitamin D supplementation has been evaluated as a way to protect the thyroid from autoimmune damage, but results from randomized clinical trials have been inconclusive. Clinical studies have shown that vitamin D3 supplementation has a unique advantage in reducing TPO antibody titers. In 2014, AACE (American Association of Clinical Endocrinologists) guidelines indicated that vitamin D can be used as a complementary treatment for Hashimoto's thyroiditis. The prevalence of vitamin D deficiency in HT patients is as high as 50%-90%. Studies have shown that VD is widely used in vivo. VD can be used as an immune factor to participate in the process of immune regulation. Cells of the immune system (B cells, T cells and antigen presenting cells) can synthesize active metabolites of vitamin D due to the expression of 1α-hydroxylase (CYP27B1), which shows immunomodulatory properties. In addition, studies have shown that Vitamin D receptor (VDR) is found not only in bone, kidneys, and intestine, but also in the immune system (T and B cells, macrophages, and monocytes), reproductive system, endocrine system, muscle, brain, skin, and liver. The expression of the vitamin D receptor in these cells suggests a local role for vitamin D in immune responses. Existing genetic studies have found that most VDR can be restricted by CYP1α and vitamin D binding proteins, showing the relationship between VDR, DBP and CYP1α gene polymorphisms and thyroid autoimmune system, which affect T and B lymphocytes, dendritic cells and macrophages, as well as enzymes with CYP1α and VDR. Therefore, Vitamin D is thought to be an immune modulator.
Clinical studies have confirmed that vitamin D deficiency is more common in patients with autoimmune thyroid disease (AITD), both in children and the elderly, and in both low and high latitudes. Combining vitamin D with anti-thyroid drugs or thyroid hormones can help treat AITD by suppressing autoimmune responses and lowering serum levels of thyroid autoantibodies. However, studies have shown that vitamin D deficiency is not associated with AITD, especially early AITD. However, a study based on Asian Indian communities found only a weak inverse association between serum 25-hydroxyvitamin D values and TPO antibody titers. A 2015 meta-analysis demonstrated that vitamin D deficiency is prevalent in AITD subjects and that these subjects have low serum 25-hydroxyvitamin D levels, suggesting that lower serum 25-hydroxyvitamin D is associated with AITD disease.
There is a complex relationship between HT and serum 25-hydroxyvitamin D. It is not clear whether the decreased serum 25-hydroxyvitamin D level is one of the causes of HT hypothyroidism or a consequence of HT.
- Conditions
- Hashimoto Thyroiditis
- Being tested
- Vitamin D Drops
- Medical subject headings
- Hashimoto Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D DropsDrug
Also called Vitamin D
Supplement 2000IU of vitamin D, no matter the brand or manufacturer for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| Serum vitamin D deficiency in Hashimoto's thyroiditis during hypothyroidism | Serum vitamin D levels are lower than normal Receives: Drug: Vitamin D Drops | |
| Patients with normal serum vitamin D during hypothyroidism in Hashimoto's thyroiditis | Serum vitamin D levels are within normal limits |
What is being measured
The primary outcome is the main question the study is designed to answer.
TPOAB in IU/ml
Thyroid peroxisomes, a thyroid autoantibodies
Measured: Data for each participant will be collected within 3 days
Secondary outcomes (4)
TGAB in IU/ml
Thyroglobulin antibody, a thyroid autoantibody
Measured: Data for each participant will be collected within 3 days
FT3 in pmol/L
Serum free triiodothyronine (FT3), one of the indicators reflecting thyroid function
Measured: Data for each participant will be collected within 3 days
FT4 in pmol/L
Serum free thyroxine (FT4), one of the indicators reflecting thyroid function
Measured: Data for each participant will be collected within 3 days
TSH in uIU/ml
Thyroid-stimulating hormone (TSH) is a hormone secreted by adenohypophysis that promotes the growth and function of thyroid gland and promotes the proliferation of thyroid follicular epithelial cells and the synthesis and release of thyroid hormone.
Measured: Data for each participant will be collected within 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hashimoto ThyroiditisStudies of the same condition, open and under way.
- More trials run by Qianfoshan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuying Cui, Study chair, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871957
- Sponsor's protocol ID
- YXLL-KY-2021(041)
- Status last verified
- May 2023
- First submitted
- 15 Oct 2022
- Last updated
- 23 May 2023
- 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 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Therapeutic Effect of Vitamin D on Hashimoto's Thyroiditis
- ClinicalTrials.gov ID
- NCT05871957
- Acronym / sponsor ID
- YXLL-KY-2021(041)
- Conditions
- Hashimoto Thyroiditis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 23 May 2023 (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 study is to explore the relationship between vitamin D and Hashimoto's thyroiditis and to explore whether vitamin D can play an adjuvant role in the treatment of Hashimoto's thyroiditis. Epidemiological surveys show that vitamin D deficiency rates are as high as 50%-90% in HT patients. Dietary supplementation with vitamin D has been evaluated as a way to protect the thyroid gland from autoimmune damage, but the results of randomized clinical trials are unclear.
Detailed description
Hashimoto's thyroiditis (HT), also known as chronic lymphocytic or autoimmune thyroiditis (AITD), is a type of chronic autoimmune thyroid disease that is associated with varying degrees of hypothyroidism, thyroid autoantibody production, and lymphocytic infiltration. In China, the incidence rate showed a rising trend year by year. For the majority of HT hypothyroidism patients, synthetic levothyroxine (LT4) (first crystallized by Kendall in 1915, commercialized in the 1930s, and mass-produced in the 1960s) remains the only effective drug for HT patients. The treatment works for most patients, but is still controversial. Dietary vitamin D supplementation has been evaluated as a way to protect the thyroid from autoimmune damage, but results from randomized clinical trials have been inconclusive. Clinical studies have shown that vitamin D3 supplementation has a unique advantage in reducing TPO antibody titers. In 2014, AACE (American Association of Clinical Endocrinologists) guidelines indicated that vitamin D can be used as a complementary treatment for Hashimoto's thyroiditis. The prevalence of vitamin D deficiency in HT patients is as high as 50%-90%. Studies have shown that VD is widely used in vivo. VD can be used as an immune factor to participate in the process of immune regulation. Cells of the immune system (B cells, T cells and antigen presenting cells) can synthesize active metabolites of vitamin D due to the expression of 1α-hydroxylase (CYP27B1), which shows immunomodulatory properties. In addition, studies have shown that Vitamin D receptor (VDR) is found not only in bone, kidneys, and intestine, but also in the immune system (T and B cells, macrophages, and monocytes), reproductive system, endocrine system, muscle, brain, skin, and liver. The expression of the vitamin D receptor in these cells suggests a local role for vitamin D in immune responses. Existing genetic studies have found that most VDR can be restricted by CYP1α and vitamin D binding proteins, showing the relationship between VDR, DBP and CYP1α gene polymorphisms and thyroid autoimmune system, which affect T and B lymphocytes, dendritic cells and macrophages, as well as enzymes with CYP1α and VDR. Therefore, Vitamin D is thought to be an immune modulator.
Clinical studies have confirmed that vitamin D deficiency is more common in patients with autoimmune thyroid disease (AITD), both in children and the elderly, and in both low and high latitudes. Combining vitamin D with anti-thyroid drugs or thyroid hormones can help treat AITD by suppressing autoimmune responses and lowering serum levels of thyroid autoantibodies. However, studies have shown that vitamin D deficiency is not associated with AITD, especially early AITD. However, a study based on Asian Indian communities found only a weak inverse association between serum 25-hydroxyvitamin D values and TPO antibody titers. A 2015 meta-analysis demonstrated that vitamin D deficiency is prevalent in AITD subjects and that these subjects have low serum 25-hydroxyvitamin D levels, suggesting that lower serum 25-hydroxyvitamin D is associated with AITD disease.
There is a complex relationship between HT and serum 25-hydroxyvitamin D. It is not clear whether the decreased serum 25-hydroxyvitamin D level is one of the causes of HT hypothyroidism or a consequence of HT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serum vitamin D deficiency in Hashimoto's thyroiditis during hypothyroidism | – | Drug: Vitamin D DropsSerum vitamin D levels are lower than normal |
| Patients with normal serum vitamin D during hypothyroidism in Hashimoto's thyroiditis | – | –Serum vitamin D levels are within normal limits |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Hashimoto's thyroiditis patients with hypothyroidism.
Key inclusion criteria (2 listed)
- Meeting the diagnostic criteria of Hashimoto's thyroiditis in Western medicine (according to the Chinese Guidelines for the Diagnosis and Treatment of Thyroid Diseases - Thyroiditis and the Guidelines for the Diagnosis and Treatment of hypothyroidism in adults).
- Signing informed consent.
Key exclusion criteria (13 listed)
- Patients with thyroid cancer;
- Other thyroid related diseases, such as Graves' disease;
- History of thyroid surgery or radioiodine therapy;
- Life history of iodine deficiency area with goiter;
- Immunosuppressive agents or immunomodulatory agents (mannan peptide, ubenamex, cyclophosphamide, incense) should be used within 1 month Polysaccharide, interferon, glucocorticoid, etc.); Other proprietary Chinese medicine (Bailing capsule, Prunella capsule, etc.)
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 |
|---|---|---|
| Vitamin D DropsAlso: Vitamin DSupplement 2000IU of vitamin D, no matter the brand or manufacturer for 1 month. | Drug | Serum vitamin D deficiency in Hashimoto's thyroiditis during hypothyroidism |
Primary outcome
TPOAB in IU/ml
Time frame: Data for each participant will be collected within 3 days
Thyroid peroxisomes, a thyroid autoantibodies
4 secondary outcomes
TGAB in IU/ml
Time frame: Data for each participant will be collected within 3 days
FT3 in pmol/L
Time frame: Data for each participant will be collected within 3 days
FT4 in pmol/L
Time frame: Data for each participant will be collected within 3 days
TSH in uIU/ml
Time frame: Data for each participant will be collected within 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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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.
Yuying Cui study chair
Qianfoshan Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Hashimoto Thyroiditis, run by Qianfoshan Hospital.
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 13 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 23 May 2023. 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. 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 Lin Liao, Doctor (18354117713, liaolin@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TPOAB in IU/ml (time frame: Data for each participant will be collected within 3 days). 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 23 May 2023.