Clinical trial NCT01115842: Vitamin D and Inflammatory Cytokine Levels After Acute Myocardial Infraction (MI)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Cytokines
Keywords: Vitamin D
Acute coronary syndrome
inflammatory cytokines
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: Clalit Health Services
First posted: 2010-05-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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.

Primary outcomes:
measure: inflammatory cytokine levels
timeFrame: 5 days of treatment
Secondary outcomes:
measure: MACE and all cause mortality
timeFrame: within 6 months
Other outcomes:
Locations:
city: Kfar-Sava
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Yoav Arnson, MD
role: PRINCIPAL_INVESTIGATOR
References: