Vitamin D and Zinc Levels in Patients Undergoing Ergometry Test

NCT ID: NCT01080274

Last Updated: 2010-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Atherosclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

positive ergometry

positive ergometry as specified by a cardiologist on site.

No interventions assigned to this group

negative ergometry.

negative ergometry as specified by cardiologist on site.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Over 18 years old
* CCT \> 60 ml/min
* No IHD
* No hyper/hypoparathyroidism
* No active malignancy
* Not taking calcium, phosphate

Exclusion Criteria

* Under 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Assaf-Harofeh Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assaf Harofeh Mc

Ẕerifin, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

22/10

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Vitamin D Treatment on Fatigue
NCT02022475 COMPLETED PHASE3