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

Graves Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993302
• Other study ID #: RSCM/FKUI
• Status: Completed
• Phase: Phase 2
• Start date: July 2014
• Est. completion date: March 2015

Study information

• Verified date: February 2020
• Source: Dr Cipto Mangunkusumo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Graves Disease

Intervention

Drug:
• 1a-D3
patients were given PTU and 1a-D3
• Placebos
patients were given PTU and placebos

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dr Cipto Mangunkusumo General Hospital	Indonesia University

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

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