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NCT01878916 Clinical Trial

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

Thrombosis Clinical Trial

Official title:
Plasma Cobalamin, Folate, Pyridoxine and Homocysteine Levels and Thrombosis in Patients With Philadelphia-chromosome-negative Myeloproliferative Neoplasms

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01878916
Other study ID # HcyMPN
Secondary ID
Status Completed
Phase N/A
First received May 29, 2013
Last updated June 14, 2013
Start date January 2003
Est. completion date June 2004

Study information
Verified date June 2013
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date June 2004
Est. primary completion date June 2004
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Istanbul University Cerrahpasa Medical Faculty Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Other Death 1 year No
Primary Thrombosis at least 1 year No
Secondary High Hcy level 1 year No
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