Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients

Study Overview
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Brief Summary
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Maturity level of dendritic cells (DC) plays a pivotal role in initiating and regulating autoimmunity. In Graves' disease (GD), DCs have more active immune responses than those in healthy subjects. Our previous study demonstrated immunoregulatory effects of in vitro 1,25-D3 on maturation of DC in GD patients. This study aims to evaluate the effect of oral 1α-D3 on DC maturation in GD patients.

Detailed Description
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Patients with Graves' disease were divided into two groups: groups receiving oral 1α-D3 in addition to propylthiouracil (PTU) and groups receiving placebos in addition to PTU. Comparison of DC maturation were performed before and after the oral 1α-D3. DC maturation was assessed based on the expression of DC markers (HLA-DR, CD80, CD40, CD83, CD14 and CD206) and the ratio of cytokines interleukin-12/IL-10.

Official Title
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Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients

Conditions
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Graves Disease

Intervention / Treatment
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* Drug: 1α-D3
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Graves' disease and still have not gone into remission Willing to participate in the research Exclusion Criteria: Pregnant patient Suffered from severe liver disease Suffered from severe kidney disease Taking vitamin D substitution therapy Suffered from another autoimmune disease Suffered from malignancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PTU-Oral 1α-D3<br>patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis | Drug: 1α-D3<br>* patients were given PTU and 1α-D3<br>* Other names: alfacalcidol;|
| Placebo Comparator: PTU-Placebos<br>patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis | Drug: Placebos<br>* patients were given PTU and placebos<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD80 Level | Dendritic cells maturation levels were measured by the CD80 (cluster of differentiation 80) | 1 year | 
| CD206 Level | Dendritic cells maturation levels were measured by the CD206 | 1 year | 
| IL-12/IL-10 Ratio | Dendritic cells maturation levels were measured by the IL-12 (interleukin-12)/IL-10 ratio | 1 year | 
| fT4 Levels | fT4 (free thyroxine) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D, graves' disease, dendritic cells