Status:
UNKNOWN
Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients
Lead Sponsor:
Augusta University
Conditions:
Cardiovascular Diseases
Chronic Kidney Disease Stage 3
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The life span of adults with end-stage renal disease is reduced, and cardiovascular disease (CVD) accounts for approximately half the deaths among those undergoing hemodialysis (HD). Vascular calcific...
Eligibility Criteria
Inclusion
- Chronic Kidney Disease Stages 3 to 5
- Receiving hemodialysis treatment for at least 3 months
- Subject understands the study protocol and agrees to comply with it
- Informed consent documents signed by subject
Exclusion
- Using vitamin supplements containing vitamin K
- History of metabolic gastrointestinal diseases
- Subjects presenting chronic degenerative and/or inflammatory diseases
- Receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)
- Subjects receiving corticosteroid
- Use of anticoagulants
- History of soy allergy
- Have an unstable medical condition, such as having a life expectancy of less than 6 months in the judgment of the investigator
- Known sensitivity, intolerance, or other adverse response to study drugs which would prevent compliance with study medication
- Subjects who have participated in a clinical study more recently than one month before the current study
Key Trial Info
Start Date :
September 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03311321
Start Date
September 13 2017
End Date
December 30 2021
Last Update
November 20 2019
Active Locations (1)
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1
Augusta University
Augusta, Georgia, United States, 30901