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Administrative data

NCT number NCT01115842
Other study ID # MMC10184-2009CTIL
Secondary ID
Status Unknown status
Phase Phase 4
First received May 2, 2010
Last updated August 19, 2010
Start date June 2010
Est. completion date January 2011

Study information

Verified date April 2010
Source Meir Medical Center
Contact Yoav Arnson, MD
Phone 09-7472899
Email yoavar@zahav.net.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Unknown status
Enrollment 50
Est. completion date January 2011
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Vitamin D
Vitamin D 4000IU per day for 5 days

Locations

Country Name City State
Israel Meir Medical Center Kfar-Sava

Sponsors (2)

Lead Sponsor Collaborator
Meir Medical Center Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary inflammatory cytokine levels CRP, TNF-a. Il-2, IL-6, IL-12 and IL-10 5 days of treatment
Secondary MACE and all cause mortality Major acute coronary events (MACE)include:
revascularization
acute coronary syndrome
unstable angina pectoris
within 6 months
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