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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

May 2, 2010
August 19, 2010
June 2010
December 2010   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01115842 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Acute Coronary Syndrome
  • Cytokines
Drug: Vitamin D
Vitamin D 4000IU per day for 5 days
  • Experimental: Vitamin D
    The patients will be given Vitamin D - 4000IU per day for 5 days (Day 1 through 5)
    Intervention: Drug: Vitamin D
  • No Intervention: control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
January 2011
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Yoav Arnson, MD 09-7472899 yoavar@zahav.net.il
Contact: Howard Amital, MD, MHA 09-7472899 Howard.Amital@clalit.org.il
Israel
 
NCT01115842
MMC10184-2009CTIL
Yes
Arnson Yoav, MD, Clalit Health Service
Meir Medical Center
Clalit Health Services
Principal Investigator: Yoav Arnson, MD Meir Medical Center
Meir Medical Center
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP