Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/19/2018 |
| Start Date: | September 13, 2017 |
| End Date: | December 2018 |
| Contact: | Norman K Pollock, PhD |
| Email: | npollock@augusta.edu |
| Phone: | 706-721-4524 |
Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients (Vita-K 'n' CKD Study)
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 calcification is a key process in the development of atherosclerotic and
arteriosclerotic CVD, and contributes significantly to the greater mortality rates and CVD
events in HD patients. Recently, there has been growing interest in the vitamin K-dependent
matrix Gla protein (MGP) and its role in inhibiting vascular calcification. Animal studies
have revealed that the vitamin K-dependent protein MGP may reduce the progression of vascular
calcification, possibly by means of improving vascular function. The relationship between MGP
and vitamin K lies in the fact that inactive matrix Gla protein requires vitamin K to
carboxylate it for its activation. Currently, data in HD patients are scant and equivocal on
the effects of vitamin K supplementation on CVD risk outcomes. Therefore, the purpose of this
8-week randomized, placebo-controlled, double-blind clinical trial is to determine whether
daily vitamin K supplementation can favorably alter measurements of endothelial function and
arterial stiffness in HD patients.
(CVD) accounts for approximately half the deaths among those undergoing hemodialysis (HD).
Vascular calcification is a key process in the development of atherosclerotic and
arteriosclerotic CVD, and contributes significantly to the greater mortality rates and CVD
events in HD patients. Recently, there has been growing interest in the vitamin K-dependent
matrix Gla protein (MGP) and its role in inhibiting vascular calcification. Animal studies
have revealed that the vitamin K-dependent protein MGP may reduce the progression of vascular
calcification, possibly by means of improving vascular function. The relationship between MGP
and vitamin K lies in the fact that inactive matrix Gla protein requires vitamin K to
carboxylate it for its activation. Currently, data in HD patients are scant and equivocal on
the effects of vitamin K supplementation on CVD risk outcomes. Therefore, the purpose of this
8-week randomized, placebo-controlled, double-blind clinical trial is to determine whether
daily vitamin K supplementation can favorably alter measurements of endothelial function and
arterial stiffness in HD patients.
Inclusion Criteria:
- 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 Criteria:
- 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
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