Vitamin D and Inflammatory Cytokine Levels After Acute Myocardial Infraction (MI)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vitamin D The patients will be given Vitamin D - 4000IU per day for 5 days (Day 1 through 5) |
Drug: Vitamin D
Vitamin D 4000IU per day for 5 days
|
| No Intervention: control
|
Outcome Measures
Primary Outcome Measures
- inflammatory cytokine levels [5 days of treatment]
CRP, TNF-α. Il-2, IL-6, IL-12 and IL-10
Secondary Outcome Measures
- MACE and all cause mortality [within 6 months]
Major acute coronary events (MACE)include: revascularization acute coronary syndrome unstable angina pectoris
Eligibility Criteria
Criteria
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-mediatory 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Meir Medical Center | Kfar-Sava | Israel |
Sponsors and Collaborators
- Meir Medical Center
- Clalit Health Services
Investigators
- Principal Investigator: Yoav Arnson, MD, Meir Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MMC10184-2009CTIL