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:
HaEmek Medical Center, Israel
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
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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 May 22, 2013