Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05871957
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-23
First Post:
2022-10-15
Brief Title:
Adjuvant Therapeutic Effect of Vitamin D on Hashimotos Thyroiditis
Sponsor:
Qianfoshan Hospital
Organization:
Qianfoshan Hospital
Study Overview
Official Title:
Adjuvant Therapeutic Effect of Vitamin D on Hashimotos Thyroiditis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to explore the relationship between vitamin D and Hashimotos thyroiditis and to explore whether vitamin D can play an adjuvant role in the treatment of Hashimotos 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:
Hashimotos 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 Hashimotos 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None