This trial is active, not recruiting.

Condition atherosclerosis
Sponsor Assaf-Harofeh Medical Center
Start date March 2010
End date March 2011
Trial size 200 participants
Trial identifier NCT01080274, 22/10


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional
positive ergometry as specified by a cardiologist on site.
negative ergometry as specified by cardiologist on site.
100 patients with positive ergometry test as specified by the cardiologist in charge. All patients are ambulatory patients referred for routine check up.

Primary Outcomes

positive stress test
time frame: one year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Vitamin D and Zinc Levels in Patients Undergoing Ergometry 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2010.
Information provided to ClinicalTrials.gov by Assaf-Harofeh Medical Center.