Acute Coronary SyndromePhase 4NCT01115842
Vitamin D and Inflammatory Cytokine Levels After Acute Myocardial Infraction (MI)
A Phase 4 study testing Vitamin D in people with Acute Coronary Syndrome and Cytokines, run by Meir Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Cytokines
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2010to Jan 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- Vitamin D
- Keywords
- Vitamin D, Acute coronary syndrome, inflammatory cytokines
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Vitamin D 4000IU per day for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | The patients will be given Vitamin D - 4000IU per day for 5 days (Day 1 through 5) Receives: Drug: Vitamin D |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammatory cytokine levels
CRP, TNF-α. Il-2, IL-6, IL-12 and IL-10
Measured: 5 days of treatment
Secondary outcomes (1)
MACE and all cause mortality
Major acute coronary events (MACE)include:
- revascularization
- acute coronary syndrome
- unstable angina pectoris
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Clalit Health Services
- Investigators
- Yoav Arnson, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115842
- Sponsor's protocol ID
- MMC10184-2009CTIL
- Status last verified
- Apr 2010
- First submitted
- 2 May 2010
- Last updated
- 20 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01115842
- Acronym / sponsor ID
- MMC10184-2009CTIL
- Conditions
- Acute Coronary Syndrome, Cytokines
- Keywords
- Vitamin D, Acute coronary syndrome, inflammatory cytokines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Clalit Health Services
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 4 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: Vitamin DThe patients will be given Vitamin D - 4000IU per day for 5 days (Day 1 through 5) |
| control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DVitamin D 4000IU per day for 5 days | Drug | Vitamin D |
Primary outcome
inflammatory cytokine levels
Time frame: 5 days of treatment
CRP, TNF-α. Il-2, IL-6, IL-12 and IL-10
1 secondary outcome
MACE and all cause mortality
Time frame: within 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoav Arnson, MD principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D in people with Acute Coronary Syndrome and Cytokines, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoav Arnson, MD (09-7472899, yoavar@zahav.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammatory cytokine levels (time frame: 5 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2010.