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

NCT01115842 | Unknown Phase 4 DMC

• 1 other identifier: MMC10184-2009CTIL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Coronary Syndrome; Cytokines

Keywords

Vitamin D; Acute coronary syndrome; inflammatory cytokines

Outcome Measures

Primary Outcomes (1)

• inflammatory cytokine levels

  CRP, TNF-α. Il-2, IL-6, IL-12 and IL-10

  5 days of treatment

Secondary Outcomes (1)

• MACE and all cause mortality

  within 6 months

Study Arms (2)

Vitamin D

EXPERIMENTAL

The patients will be given Vitamin D - 4000IU per day for 5 days (Day 1 through 5)

Drug: Vitamin D

control

NO INTERVENTION

Interventions

Vitamin D DRUG

Vitamin D 4000IU per day for 5 days

Vitamin D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meir Medical Center: lead
• Clalit Health Services: collaborator

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Yoav Arnson, MD

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoav Arnson, MD

CONTACT

09-7472899; yoavar@zahav.net.il

Howard Amital, MD, MHA

CONTACT

09-7472899; Howard.Amital@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2010
• First Posted: May 4, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: August 20, 2010

Record last verified: 2010-04

Locations

IL (1)