AtherosclerosisNCT01080274
Vitamin D and Zinc Levels in Patients Undergoing Ergometry Test
An observational study of Atherosclerosis, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Low vitamin D levels were found to be associated with cardiovascular morbidity and mortality. Low zinc levels are associated with an increased atherosclerotic burden. Therefore we hypothesized that patients with pathological stress test would have low levels of Vitamin D and zinc compared to patients with a normal… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2010to Mar 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Over 18 years old * CCT > 60 ml/min * No IHD * No hyper/hypoparathyroidism * No active malignancy * Not taking calcium, phosphate
Who may be able to join
- Over 18 years old
- CCT > 60 ml/min
- No IHD
- No hyper/hypoparathyroidism
- No active malignancy
- Not taking calcium, phosphate
Who cannot join
- Under 18 years of age
- Not fulfilling inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Low vitamin D levels were found to be associated with cardiovascular morbidity and mortality. Low zinc levels are associated with an increased atherosclerotic burden. Therefore we hypothesized that patients with pathological stress test would have low levels of Vitamin D and zinc compared to patients with a normal stress test.
Read the detailed description
Hypovitaminosis D is generally defined as 25(OH)D levels of < 20ng/ml, while levels of 21-29ng/ml indicate insufficiency and those above 30ng/ml are regarded as sufficient.
The rational behind the observations associating vitamin D deficiency with CVD is that on the one hand, hypovitaminosis D was found to be associated with traditional risk factors such as hypertension (HTN),diabetes mellitus (dm),obesity, dyslipidemia and metabolic syndrome , on the other hand, experimental data demonstrated that vitamin D could affect cardiac muscle cells directly, control parathyroid (PTH) hormone secretion, regulate the rennin- angiotensin- aldosterone system and the immune system, all of which could influence cardiovascular risk.
Epidemiological studies further support this association, demonstrating high prevalence of hypovitaminosis D among U.S. adults with cardiovascular disease (74%). An association between low vitamin D levels and increased myocardial infarction risk as well as total mortality has been also observed.
Low 25hydroxyvitamin D[ 25(OH)D] levels were also independently associated with all cause and CVD mortality among patients scheduled for coronary catheterization.
- Conditions
- Atherosclerosis
- Keywords
- ergometry, vitamin d, zinc
- Medical subject headings
- Atherosclerosis
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 |
|---|---|---|
| positive ergometry | positive ergometry as specified by a cardiologist on site. | |
| negative ergometry. | negative ergometry as specified by cardiologist on site. | |
| patients with positive stress test | 100 patients with positive ergometry test as specified by the cardiologist in charge. All patients are ambulatory patients referred for routine check up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive stress test
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080274
- Sponsor's protocol ID
- 22/10
- Status last verified
- Feb 2010
- First submitted
- 3 Mar 2010
- Last updated
- 7 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Zinc Levels in Patients Undergoing Ergometry Test
- ClinicalTrials.gov ID
- NCT01080274
- Acronym / sponsor ID
- 22/10
- Conditions
- Atherosclerosis
- Keywords
- ergometry, vitamin d, zinc
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 4 Mar 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.
Low vitamin D levels were found to be associated with cardiovascular morbidity and mortality. Low zinc levels are associated with an increased atherosclerotic burden. Therefore we hypothesized that patients with pathological stress test would have low levels of Vitamin D and zinc compared to patients with a normal stress test.
Detailed description
Hypovitaminosis D is generally defined as 25(OH)D levels of < 20ng/ml, while levels of 21-29ng/ml indicate insufficiency and those above 30ng/ml are regarded as sufficient.
The rational behind the observations associating vitamin D deficiency with CVD is that on the one hand, hypovitaminosis D was found to be associated with traditional risk factors such as hypertension (HTN),diabetes mellitus (dm),obesity, dyslipidemia and metabolic syndrome , on the other hand, experimental data demonstrated that vitamin D could affect cardiac muscle cells directly, control parathyroid (PTH) hormone secretion, regulate the rennin- angiotensin- aldosterone system and the immune system, all of which could influence cardiovascular risk.
Epidemiological studies further support this association, demonstrating high prevalence of hypovitaminosis D among U.S. adults with cardiovascular disease (74%). An association between low vitamin D levels and increased myocardial infarction risk as well as total mortality has been also observed.
Low 25hydroxyvitamin D[ 25(OH)D] levels were also independently associated with all cause and CVD mortality among patients scheduled for coronary catheterization.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| positive ergometry | – | –positive ergometry as specified by a cardiologist on site. |
| negative ergometry. | – | –negative ergometry as specified by cardiologist on site. |
| patients with positive stress test | – | –100 patients with positive ergometry test as specified by the cardiologist in charge. All patients are ambulatory patients referred for routine check up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Over 18 years old * CCT > 60 ml/min * No IHD * No hyper/hypoparathyroidism * No active malignancy * Not taking calcium, phosphate
Key inclusion criteria (6 listed)
- Over 18 years old
- CCT > 60 ml/min
- No IHD
- No hyper/hypoparathyroidism
- No active malignancy
Key exclusion criteria (2 listed)
- Under 18 years of age
- Not fulfilling inclusion criteria
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
positive stress test
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Atherosclerosis, 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 6 inclusion and 2 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 7 Apr 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?
Results are not available in the source record.
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.
What does the primary outcome measure?
positive stress test (time frame: one year). 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 7 Apr 2010.