Trials / Unknown
UnknownNCT03311321
Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients
Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients (Vita-K 'n' CKD Study)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Augusta University · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
- Cardiovascular Diseases
- Chronic Kidney Disease Stage 3
- Chronic Kidney Disease Stage 4
- Chronic Kidney Disease Stage 5
- Vitamin K Deficiency
- Hemodialysis
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Vitamin K2 (menaquinone-7; 360-mcg/d) | four 90-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks |
| DIETARY_SUPPLEMENT | Placebo-Control | four placebo softgel capsules per day for 8 weeks containing no vitamin K2 (menaquinone-7) |
Timeline
- Start date
- 2017-09-13
- Primary completion
- 2021-12-01
- Completion
- 2021-12-30
- First posted
- 2017-10-17
- Last updated
- 2019-11-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03311321. Inclusion in this directory is not an endorsement.