Intervention Study Measuring Inflammatory Cytokine Levels in the Serum of Patients Who Underwent an Acute MI, and the Influence of Vitamin D on These Levels
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- inflammatory cytokine levels
研究概览
简要总结
Vitamin D is known to have immune-modulator effects including suppression of proinflammatory cytokine expression and regulation of immune cell activity. Vitamin D supplementation has been associated with a reduction in pro-inflammatory cytokines in patients with heart failure, and vitamin D deficiency has been associated with higher rates of myocardial infarcts. The levels of pro and anti-inflammatory cytokines also effect the outcome after acute coronary events.
The proposed interventional study is targeted as a feasibility study targeted at assessing the role of vitamin D as an anti-inflammatory mediator.
The study is planned as a randomized open label interventional trial. The study will be conducted of 50 adult patients (25 interventional group, 25 control), all from the internal ward in "Meir" medical center. Patients which are admitted after an acute coronary event will be randomized to the Vitamin D supplementation group or to the control group. the vitamin D group will receive 4000IU per day of vitamin D for five days. Cytokine levels will be measured at day 1 and at day 5. follow up will be continued for 6 months
Primary end point:
Levels of immune mediating cytokines (CRP, TNF-α. Il-2, IL-6, IL-12 and IL-10) after a five day intervention in patients serum.
Secondary endpoints:
Any major cardiovascular event within follow-up period. Any death of any cause during follow-up period
Expected results:
the investigators expect vitamin D supplementation after a pro-inflammatory state such as an acute coronary event, combined with conventional therapy, to result in decreased levels of inflammatory serum bio-markers.
详细描述
Inclusion criteria:
- Acute coronary syndrome (as defined previously).
- No advanced renal disease (creatinine levels < 1.8 for men and 1.5 for women).
- No known parathyroid or calcium homeostasis abnormalities
- Baseline Calcium levels within normal limits.
- No vitamin D supplementation taken within 4 months of current admission.
- No coexisting pro-inflammatory conditions (e.g. infection, active autoimmune disease)
- No coexisting immune-mediator agents (e.g. corticosteroids, anti-TNF or other biological agents).
- No participation in other interventional studies.
- Signing an informed consent form.
Exclusion criteria:
- Advanced renal failure
- Abnormal serum calcium levels upon admission
- Primary parathyroid or calcium homeostasis abnormalities.
- Coexisting pro-inflammatory conditions (e.g. infection, active autoimmune disease)
- Coexisting immune-mediator agents (e.g. corticosteroids, anti-TNF or other biological agents)
- Participation in other interventional studies.
- Inability or refusal to sign an informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Acute coronary syndrome (as defined previously).
- •No advanced renal disease (creatinine levels < 1.8 for men and 1.5 for women).
- •No known parathyroid or calcium homeostasis abnormalities
- •Baseline Calcium levels within normal limits.
- •No vitamin D supplementation taken within 4 months of current admission.
- •No coexisting pro-inflammatory conditions (e.g. infection, active autoimmune disease)
- •No coexisting immune-mediatory agents (e.g. corticosteroids, anti-TNF or other biological agents).
- •No participation in other interventional studies.
- •Signing an informed consent form.
排除标准
- •Advanced renal failure
- •Abnormal serum calcium levels upon admission
- •Primary parathyroid or calcium homeostasis abnormalities.
- •Coexisting pro-inflammatory conditions (e.g. infection, active autoimmune disease)
- •Coexisting immune-mediator agents (e.g. corticosteroids, anti-TNF or other biological agents)
- •Participation in other interventional studies.
- •Inability or refusal to sign an informed consent.
研究组 & 干预措施
Vitamin D
The patients will be given Vitamin D - 4000IU per day for 5 days (Day 1 through 5)
干预措施: Vitamin D (Drug)
结局指标
主要结局
inflammatory cytokine levels
时间窗: 5 days of treatment
CRP, TNF-α. Il-2, IL-6, IL-12 and IL-10
次要结局
- MACE and all cause mortality(within 6 months)