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

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Coronary Syndrome; Cytokines
• Intervention / Treatment: Drug: Vitamin D

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Kfar-Sava, Israel
    • Recruiting
    • Meir Medical Center
    • Contact: Yoav Arnson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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-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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inflammatory cytokine levels	CRP, TNF-α. Il-2, IL-6, IL-12 and IL-10	5 days of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE and all cause mortality	Major acute coronary events (MACE)include: revascularization; acute coronary syndrome; unstable angina pectoris	within 6 months

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Collaborators: Clalit Health Services
• Investigators: Principal Investigator: Yoav Arnson, MD, Meir Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): January 1, 2011

Study Registration Dates

• First Submitted: May 2, 2010
• First Submitted That Met QC Criteria: May 3, 2010
• First Posted (Estimate): May 4, 2010

Study Record Updates

• Last Update Posted (Estimate): August 20, 2010
• Last Update Submitted That Met QC Criteria: August 19, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Vitamin D; Acute coronary syndrome; inflammatory cytokines
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: MMC10184-2009CTIL