Vitamin D and Zinc Levels in Patients Undergoing Ergometry Test

• Conditions: Atherosclerosis

• Registration Number: NCT01080274
• Lead Sponsor: Assaf-Harofeh Medical Center

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 Timeline

• Status Verified: 2010-02
• Study Start: 2010-03
• Study First Submitted: 2010-03-03
• Study First Submitted QC: 2010-03-03
• Study First Posted: 2010-03-04
• Last Update Submitted: 2010-04-06
• Last Update Posted: 2010-04-07
• Primary Completion: 2011-03
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
positive stress test	one year

Trial Locations

Locations (1)

Assaf Harofeh Mc; 🇮🇱 Zerifin, Israel