NCT01761669

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 7, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

November 3, 2016

Status Verified

December 1, 2014

Enrollment Period

2 months

First QC Date

December 4, 2012

Last Update Submit

November 2, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • the correlation between vitamin D levels and endogenous thrombin potential

    one blood test

    3 month

Study Arms (1)

healthy voulnters

Drug: Vitamin D

Interventions

healthy voulnters

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

400 healthy volunteers

You may not qualify if:

  • no exc criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HaEmekMC

Afula, 19101, Israel

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • mazen elias, MD

    Emek Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Internal Medicine C

Study Record Dates

First Submitted

December 4, 2012

First Posted

January 7, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2013

Study Completion

July 1, 2013

Last Updated

November 3, 2016

Record last verified: 2014-12

Locations