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| Name | Class |
|---|---|
| Clalit Health Services | OTHER |
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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:
Exclusion criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental | The patients will be given Vitamin D - 4000IU per day for 5 days (Day 1 through 5) |
|
| control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | Vitamin D 4000IU per day for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| inflammatory cytokine levels | CRP, TNF-α. Il-2, IL-6, IL-12 and IL-10 | 5 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| MACE and all cause mortality | Major acute coronary events (MACE)include:
| within 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoav Arnson, MD | Contact | 09-7472899 | yoavar@zahav.net.il | |
| Howard Amital, MD, MHA | Contact | 09-7472899 | Howard.Amital@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Yoav Arnson, MD | Meir Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Medical Center | Recruiting | Kfar Saba | Israel |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 23, 2011 | |
| Reset | Nov 29, 2011 | |
| Release | Feb 20, 2013 | |
| Reset | Mar 27, 2013 | |
| Release | May 8, 2014 | |
| Unrelease | Yes | |
| Release | Aug 19, 2015 | |
| Reset | Sep 21, 2015 | |
| Release | Mar 15, 2016 | |
| Reset | Apr 13, 2016 | |
| Release | Sep 9, 2021 | |
| Reset | Oct 6, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 23, 2011 | Nov 29, 2011 | |||
| Feb 20, 2013 |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Mar 27, 2013 |
| May 8, 2014 | Yes |
| Aug 19, 2015 | Sep 21, 2015 |
| Mar 15, 2016 | Apr 13, 2016 |
| Sep 9, 2021 | Oct 6, 2021 |