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NCT01761669 Clinical Trial

Does Deficiency in Vitamin D Induced Hypercoagulation or Thrombin Generation

Cardiovascular Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01761669
Other study ID # vitamin D
Secondary ID
Status Completed
Phase N/A
First received December 4, 2012
Last updated November 2, 2016
Start date April 2013
Est. completion date July 2013

Study information
Verified date December 2014
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational [Patient Registry]

Clinical Trial Summary

Working hypothesis and aims: The aim of our study is to investigate whether vitamin D deficiency could cause increased thrombin generation and a hypercoagulable state healthy volunteers.

Methods:

In total 400 healthy volunteers are planned for inclusion in this trial. After signing an informed consent two blood samples will be obtained from each participant.

Expected results: invastigator expect to find that volunteers with vitamin D deficiency will have thrombin generation curve compatible with hypercoagulable state and returning to normal after treatment with vitamin D

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date July 2013
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria: age >18 healthy naive to drug treatment -

Exclusion Criteria:

no exc criteria

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Vitamin D

Locations
Country Name City State
Israel HaEmekMC Afula

Sponsors (1)
Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary the correlation between vitamin D levels and endogenous thrombin potential one blood test 3 month No
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