Vitamin D and Zinc Levels in Patients Undergoing Ergometry Test

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2010 by Assaf-Harofeh Medical Center.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Assaf-Harofeh Medical Center

ClinicalTrials.gov Identifier:

NCT01080274

First received: March 3, 2010

Last updated: April 6, 2010

Last verified: February 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	March 3, 2010
Last Updated Date	April 6, 2010
Start Date ^ICMJE	March 2010
Estimated Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 3, 2010)	positive stress test [ Time Frame: one year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01080274 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Vitamin D and Zinc Levels in Patients Undergoing Ergometry Test
Official Title ^ICMJE	Vitamin D and Zinc Levels in Patients Undergoing Ergometry Test
Brief 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 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 Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA Description: blood will be collected for vit d and zinc , stored until all samples are collected and only than the laboratoty will analyze it.
Sampling Method	Non-Probability Sample
Study Population	Over 18 years old CCT > 60 ml/min No IHD No hyper/hypoparathyroidism No active malignancy Not taking calcium, phosphate
Condition ^ICMJE	Atherosclerosis
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	200
Estimated Completion Date	March 2011
Estimated Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 Not fulfilling inclusion criteria
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT01080274
Other Study ID Numbers ^ICMJE	22/10
Has Data Monitoring Committee	No
Responsible Party	Renana Shor MD, Assaf-Harofeh Medical Center
Study Sponsor ^ICMJE	Assaf-Harofeh Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Assaf-Harofeh Medical Center
Verification Date	February 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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