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Does Deficiency in Vitamin D Induced Hypercoagulation or Thrombin Generation

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ClinicalTrials.gov Identifier: NCT01761669
Recruitment Status : Completed
First Posted : January 7, 2013
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Elias mazen, HaEmek Medical Center, Israel

Brief 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


Condition or disease Intervention/treatment
Cardiovascular Disease Drug: Vitamin D

Study Type : Observational [Patient Registry]
Actual Enrollment : 400 participants
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Study Start Date : April 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

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

Group/Cohort Intervention/treatment
healthy voulnters Drug: Vitamin D



Primary Outcome Measures :
  1. the correlation between vitamin D levels and endogenous thrombin potential [ Time Frame: 3 month ]
    one blood test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761669


Locations
Israel
HaEmekMC
Afula, Israel, 19101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: mazen elias, MD Emek medical center

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
First Posted: January 7, 2013    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: December 2014

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