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Plasma Vitamin and Homocysteine Levels and Thrombosis in Patients With Ph-negative MPNs

Sponsor
Istanbul University (Other)
Overall Status
Completed
CT.gov ID
NCT01878916
Collaborator
(none)
1
Location
17
Duration (Months)

Study Details

Study Description

Brief Summary

Hyperhomocysteinemia is a risk for thrombosis. Thrombosis is more frequent in myeloproliferative neoplasms (MPNs) than the normal population. In this study, we investigated the thrombosis incidence, the effects of plasma homocysteine levels on thrombosis, and the correlations between folate, cobalamin, pyridoxine and homocysteine levels in MPNs, and to compare these results with the healthy controls.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Thirty-one new or formerly diagnosed MPN patients who consecutively visitted our outpatient clinic, as well as 40 age and sex matched healthy controls were enrolled in this study.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Plasma Cobalamin, Folate, Pyridoxine and Homocysteine Levels and Thrombosis in Patients With Philadelphia-chromosome-negative Myeloproliferative Neoplasms
    Study Start Date :
    Jan 1, 2003
    Actual Primary Completion Date :
    Jun 1, 2004
    Actual Study Completion Date :
    Jun 1, 2004

    Outcome Measures

    Primary Outcome Measures

    1. Thrombosis [at least 1 year]

    Secondary Outcome Measures

    1. High Hcy level [1 year]

    Other Outcome Measures

    1. Death [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Adult MPN patients and healthy controls who gave a written consent were included in the study.

    Exclusion Criteria:

    Exclusion criteria included not giving a written consent and using medications without an indication which may have an effect on plasma homocysteine and vitamin levels.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istanbul University Cerrahpasa Medical Faculty Istanbul Turkey

    Sponsors and Collaborators

    • Istanbul University

    Investigators

    • Principal Investigator: Ahmet Emre Eskazan, MD, Istanbul University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. A. Emre Eşkazan, MD, Istanbul University
    ClinicalTrials.gov Identifier:
    NCT01878916
    Other Study ID Numbers:
    • HcyMPN
    First Posted:
    Jun 17, 2013
    Last Update Posted:
    Jun 17, 2013
    Last Verified:
    Jun 1, 2013
    Keywords provided by Dr. A. Emre Eşkazan, MD, Istanbul University
    the incidence of thrombosis,
    the effect of Hcy on thrombosis formation,
    the relation between Hcy and plasma vitamin levels,
    to compare these results with the control group
    Additional relevant MeSH terms:
    Thrombosis

    Study Results

    No Results Posted as of Jun 17, 2013