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

NCT ID: NCT01115842

Last Updated: 2010-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-01-31

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.

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.

Conditions

Acute Coronary Syndrome; Cytokines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Vitamin D

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

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

Vitamin D 4000IU per day for 5 days

control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vitamin D

Vitamin D 4000IU per day for 5 days

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clalit Health Services

OTHER

Sponsor Role: collaborator

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Clalit Health Service

Principal Investigators

Yoav Arnson, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

Meir Medical Center

Kfar Saba, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Yoav Arnson, MD

Role: CONTACT

yoavar@zahav.net.il

09-7472899

Howard Amital, MD, MHA

Role: CONTACT

Howard.Amital@clalit.org.il

09-7472899

Facility Contacts

Yoav Arnson

Role: primary

Other Identifiers

MMC10184-2009CTIL

Identifier Type: -

Identifier Source: org_study_id