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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
  Purpose

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.


Condition
Atherosclerosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Vitamin D and Zinc Levels in Patients Undergoing Ergometry Test

Resource links provided by NLM:

Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • positive stress test [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood will be collected for vit d and zinc , stored until all samples are collected and only than the laboratoty will analyze it.


Estimated Enrollment: 200
Study Start Date: March 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080274

Locations
Israel
Assaf Harofeh Mc
Zerifin, Israel
Sponsors and Collaborators
Assaf-Harofeh Medical Center
  More Information

No publications provided

Responsible Party: Renana Shor MD, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01080274     History of Changes
Other Study ID Numbers: 22/10
Study First Received: March 3, 2010
Last Updated: April 6, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:
ergometry
vitamin d
zinc

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Vitamin D
Ergocalciferols
 Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013