Does Deficiency in Vitamin D Induced Hypercoagulation or Thrombin Generation

This study is currently recruiting participants. (see Contacts and Locations)
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 13, 2014
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 2014
Estimated Primary Completion Date: August 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 13, 2014
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on August 28, 2014