Does Deficiency in Vitamin D Induced Hypercoagulation or Thrombin Generation

This study is currently recruiting participants.
Verified May 2013 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
Elias mazen, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01761669
First received: December 4, 2012
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention
Cardiovascular Disease
Drug: Vitamin D

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 3 Months

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • the correlation between vitamin D levels and endogenous thrombin potential [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    one blood test


Estimated Enrollment: 400
Study Start Date: December 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
healthy voulnters Drug: Vitamin D

  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

400 healthy volunteers

Criteria

Inclusion Criteria: age >18 healthy naive to drug treatment -

Exclusion Criteria:

no exc criteria

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761669

Contacts
Contact: mazen elias, MD 972-4-6495139 elias_m@clalit.org.il

Locations
Israel
HaEmekMC Recruiting
Afula, Israel, 19101
Contact: elias mazen, prof    972-6495139    elias_m@clalit.org.il   
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: mazen elias, MD Emek medical center
Principal Investigator: mazen Elias, MD Emek medical center
  More Information

No publications provided

Responsible Party: Elias mazen, Director of Internal Medicine C, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01761669     History of Changes
Other Study ID Numbers: vitamin D
Study First Received: December 4, 2012
Last Updated: May 6, 2013
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
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 April 23, 2014