Vitamin D and Inflammatory Cytokine Levels After Acute Myocardial Infraction (MI)
Status:
Unknown status
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
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.