Effect of Alfacalcidol Supplementation to Respiratory Infection, Inflammatory Markers and CD4/CD8 Ratio of Indonesian Elderly
试验速览
- 阶段
- 4 期
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- upper respiratory tract infection incidence
研究概览
简要总结
Vitamin D has been known to influence immune response through Vitamin D Receptor in Immune Cells, but only few has been known about the effect alfacalcidol, a vitamin D analog to immune system. In elderly, immune disregulation or immunosenecence have great impact to infection response. This study is aimed to determine the effect of alfacalcidol supplementation in vitro and in vivo to respiratory infection incidence and inflammatory markers, as well as T cell lymphocyte subset in Indonesian elderly patients.
详细描述
This study consist of 2 designs. First is in vitro study to investigate the effect of alfacalcidol supplementation to IL-6, IL-10 and IFN gamma regulation in Peripheral Blood Mononuclear Cells (PBMC) of elderly and second design is randomised controlled trial to evaluate the effect of 3 months supplementation of alfacalcidol 0,5 mcg in respiratory infection, antibiotic use, inflammatory markers, CD4/CD8 ratio and CD8+ CD28+ in Indonesian elderly with various level of frailty syndrome.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elderly age more than 60
- •Willing to join research
排除标准
- •In acute infection
- •Using NSAID or steroid
- •Liver failure
- •Hypercalcemia
研究组 & 干预措施
Alfacalcidol
Alfacalcidol 0,5 mcg once daily for 90 days
干预措施: Alfacalcidol (Drug)
Placebo
Amylum same capsule form, weight and colour with treatment arm
干预措施: Alfacalcidol (Drug)
结局指标
主要结局
upper respiratory tract infection incidence
时间窗: 90 days
incidence of URTI
lower respiratory tract infection incidence
时间窗: 90 days
incidence of LRTI
次要结局
- inflammatory markers(day 90)
- antibiotic use(90 days)
- T cell subset(day 90)