Does Deficiency in Vitamin D Induced Hypercoagulation or Thrombin Generation

November 2, 2016 updated by: Elias mazen, HaEmek Medical Center, Israel

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 19101
        • HaEmekMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

400 healthy volunteers

Description

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

Exclusion Criteria:

no exc criteria

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the correlation between vitamin D levels and endogenous thrombin potential
Time Frame: 3 month
one blood test
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

December 4, 2012

First Submitted That Met QC Criteria

January 2, 2013

First Posted (ESTIMATE)

January 7, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vitamin D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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