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NCT01080274 Clinical Trial

Vitamin D and Zinc Levels in Patients Undergoing Ergometry Test

Atherosclerosis Clinical Trial

Official title:
Vitamin D and Zinc Levels in Patients Undergoing Ergometry Test

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01080274
Other study ID # 22/10
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 3, 2010
Last updated April 6, 2010
Start date March 2010
Est. completion date March 2011

Study information
Verified date February 2010
Source Assaf-Harofeh Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical 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 stress test.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 200
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Assaf Harofeh Mc Zerifin

Sponsors (1)
Lead Sponsor Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary positive stress test one year No
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