Vitamin D and Inflammatory Cytokine Levels After Acute Myocardial Infraction (MI)
Recruitment status was: Recruiting
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.
Any major cardiovascular event within follow-up period. Any death of any cause during follow-up period
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||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|
- inflammatory cytokine levels [ Time Frame: 5 days of treatment ] [ Designated as safety issue: No ]CRP, TNF-α. Il-2, IL-6, IL-12 and IL-10
- MACE and all cause mortality [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
Major acute coronary events (MACE)include:
- acute coronary syndrome
- unstable angina pectoris
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||January 2011|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115842
|Meir Medical Center|
|Principal Investigator:||Yoav Arnson, MD||Meir Medical Center|