Vitamin D and Inflammatory Cytokine Levels After Acute Myocardial Infraction (MI)

Clalit Health Services

Status and phase

Unknown

Phase 4

Conditions

Acute Coronary Syndrome

Cytokines

Treatments

Drug: Vitamin D

Study type

Interventional

Funder types

Other

Identifiers

NCT01115842

MMC10184-2009CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.