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

Dr Cipto Mangunkusumo General Hospital

Status and phase: Completed; Phase 2

Conditions: Graves Disease

Treatments: Drug: Placebos; Drug: 1α-D3

Study type: Interventional

Funder types: Other

Identifiers

NCT02993302

RSCM/FKUI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

PTU-Oral 1α-D3

Active Comparator group

Description:

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

Treatment:

Drug: 1α-D3

PTU-Placebos

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebos