Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 主要终点
- CD80 Level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Graves' disease and still have not gone into remission
- •Willing to participate in the research
排除标准
- •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
研究组 & 干预措施
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
干预措施: 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
干预措施: Placebos (Drug)
结局指标
主要结局
CD80 Level
时间窗: 1 year
Dendritic cells maturation levels were measured by the CD80 (cluster of differentiation 80)
CD206 Level
时间窗: 1 year
Dendritic cells maturation levels were measured by the CD206
IL-12/IL-10 Ratio
时间窗: 1 year
Dendritic cells maturation levels were measured by the IL-12 (interleukin-12)/IL-10 ratio
fT4 Levels
时间窗: 1 year
fT4 (free thyroxine)
次要结局
未报告次要终点
研究者
Dyah Purnamasari
M.D., Ph.D
Dr Cipto Mangunkusumo General Hospital