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

Acute Coronary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01115842
• Other study ID #: MMC10184-2009CTIL
• Status: Unknown status
• Phase: Phase 4
• First received: May 2, 2010
• Last updated: August 19, 2010
• Start date: June 2010
• Est. completion date: January 2011

Study information

• Verified date: April 2010
• Source: Meir Medical Center
• Contact: Yoav Arnson, MD
• Phone: 09-7472899
• Email: yoavar[@]zahav.net.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 50
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cytokines

Intervention

Drug:
• Vitamin D
Vitamin D 4000IU per day for 5 days

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar-Sava

Sponsors (2)

Lead Sponsor	Collaborator
Meir Medical Center	Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammatory cytokine levels	CRP, TNF-a. Il-2, IL-6, IL-12 and IL-10	5 days of treatment
Secondary	MACE and all cause mortality	Major acute coronary events (MACE)include: revascularization; acute coronary syndrome; unstable angina pectoris	within 6 months