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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Clalit Health Services
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01115842
First received: May 2, 2010
Last updated: August 19, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Cytokines
Drug: Vitamin D
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • inflammatory cytokine levels [ Time Frame: 5 days of treatment ] [ Designated as safety issue: No ]
    CRP, TNF-α. Il-2, IL-6, IL-12 and IL-10


Secondary Outcome Measures:
  • MACE and all cause mortality [ Time Frame: within 6 months ] [ Designated as safety issue: No ]

    Major acute coronary events (MACE)include:

    • revascularization
    • acute coronary syndrome
    • unstable angina pectoris


Estimated Enrollment: 50
Study Start Date: June 2010
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: control

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115842

Contacts
Contact: Yoav Arnson, MD 09-7472899 yoavar@zahav.net.il
Contact: Howard Amital, MD, MHA 09-7472899 Howard.Amital@clalit.org.il

Locations
Israel
Meir Medical Center Recruiting
Kfar-Sava, Israel
Contact: Yoav Arnson         
Sponsors and Collaborators
Meir Medical Center
Clalit Health Services
Investigators
Principal Investigator: Yoav Arnson, MD Meir Medical Center
  More Information

No publications provided

Responsible Party: Arnson Yoav, MD, Clalit Health Service
ClinicalTrials.gov Identifier: NCT01115842     History of Changes
Other Study ID Numbers: MMC10184-2009CTIL
Study First Received: May 2, 2010
Last Updated: August 19, 2010
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Meir Medical Center:
Vitamin D
Acute coronary syndrome
inflammatory cytokines

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Disease
Pathologic Processes
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 01, 2014