Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Primary Endpoint
- CD80 Level
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
PTU-Oral 1α-D3
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
Intervention: 1α-D3 (Drug)
PTU-Placebos
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
Intervention: Placebos (Drug)
Outcomes
Primary Outcomes
CD80 Level
Time Frame: 1 year
Dendritic cells maturation levels were measured by the CD80 (cluster of differentiation 80)
CD206 Level
Time Frame: 1 year
Dendritic cells maturation levels were measured by the CD206
IL-12/IL-10 Ratio
Time Frame: 1 year
Dendritic cells maturation levels were measured by the IL-12 (interleukin-12)/IL-10 ratio
fT4 Levels
Time Frame: 1 year
fT4 (free thyroxine)
Secondary Outcomes
No secondary outcomes reported
Investigators
Dyah Purnamasari
M.D., Ph.D
Dr Cipto Mangunkusumo General Hospital