Vitamin D DeficiencyNCT00749541
Vitamin d Levels and Coronary Catheterization
An observational study of Vitamin D Deficiency, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
decreased vitamin d levels are associated with increased inflammatory markers,and renin angiotensin levels. decreased levels were also found to be connected to increased cardiovascular mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Deficiency
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2008to Aug 2009
- Phase
- Observational
- 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
Study population: patients undergoing an elective coronary catheterization over the age of 18.
Who may be able to join
- >18 years,
- no known ihd
Who cannot join
- renal failure ,
- medications including vitamin d, calcium ,phosphate
- hyper or hypoparathyroidism,
- abnormal calcium or phosphate values,
- known pathological coronary catheterization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 25 Hydroxy Vitamin d Levels in Patients Undergoing an Elective Coronary Catheterization
decreased vitamin d levels are associated with increased inflammatory markers,and renin angiotensin levels.
decreased levels were also found to be connected to increased cardiovascular mortality.
we therefore hypothesise that in patients with pathological results of coronary catheterization we will find decreased levels of 25 hydroxy vitamin d.
we will examine patients undergoing elective coronary catheterization and compare two groups: those with normal results and those with pathological results.
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin d coronary catheterization
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1normal catheter. | Not described | |
| abnormal catheter. | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startNov 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- renana shor, md, Principal investigator, assaf harofeh mc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749541
- Sponsor's protocol ID
- vitamin d
- Status last verified
- Sep 2008
- First submitted
- 7 Sep 2008
- Last updated
- 16 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 25 Hydroxy Vitamin d Levels in Patients Undergoing an Elective Coronary Catheterization
- ClinicalTrials.gov ID
- NCT00749541
- Acronym / sponsor ID
- vitamin d
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin d coronary catheterization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Nov 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 9 Sep 2008 (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.
decreased vitamin d levels are associated with increased inflammatory markers,and renin angiotensin levels.
decreased levels were also found to be connected to increased cardiovascular mortality.
we therefore hypothesise that in patients with pathological results of coronary catheterization we will find decreased levels of 25 hydroxy vitamin d.
we will examine patients undergoing elective coronary catheterization and compare two groups: those with normal results and those with pathological results.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1normal catheter. | – | – |
| abnormal catheter. | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing an elective coronary catheterization over the age of 18.
Key inclusion criteria (2 listed)
- >18 years,
- no known ihd
Key exclusion criteria (5 listed)
- renal failure ,
- medications including vitamin d, calcium ,phosphate
- hyper or hypoparathyroidism,
- abnormal calcium or phosphate values,
- known pathological coronary catheterization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 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.
renana shor, md principal investigator
assaf harofeh mc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency, run by Assaf-Harofeh 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 16 Dec 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 16 Dec 2010.