Clinical Trial: Risk Factors for Vascular Calcifications in Hemodialysis Patients: to What Extent is Vitamin K2 Deficiency Involved?
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Risk Factors for Vascular Calcifications in Hemodialysis Patients: to What Extent is Vitamin K2 Deficiency Involved?
Brief Summary:
Vitamin K2 deficiency has been shown to be profound in hemodialysis patients. It is reflected by high plasma levels of dephosphorylated-undercarboxylated Matrix Gla protein (dp-ucMGP) and seems to be correlated with vascular calcifications. Vascular calcifications can be assessed using the AC24 score on a lateral abdominal X-ray.
The aim of this study is to assess first the rate of decrease of dp-ucMGP in a hemodialysis cohort after supplementation with vitamin K2 and the correlation between this rate of decrease and the Aortic Calcification Severity (AC24) score. The factors associated with high levels of dp-ucMGP will be analyzed as well.
Detailed Summary:
Background The majority of patients reaching end-stage renal disease (ESRD) and dialysis have vascular calcifications. Those vascular calcifications tend to increase mortality in this specific population. It has been shown that high scores of vascular calcifications in a healthy patient with no cardiovascular risk factors lead to a higher mortality rate compared with someone with ≥3 risk factors without calcification. In hemodialysis (HD) patients, cardiovascular risk factors are numerous and they include the traditional ones such as age, smoking, diabetes, hypertension, hyperlipidemia and those specific to chronic kidney disease (CKD) as for instance hyperparathyroidism. All those facts are compelling arguments to look seriously for a treatment against vascular calcifications. Therefore the 2009 Kidney disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) has suggested to measure those vascular calcifications scores by a lateral abdominal radiograph that is a cost-effective alternative to the standard computed tomography-based imaging.
In order to lower or prevent vascular calcifications in chronic kidney disease (CKD) patients, many interventions have been studied in the past. They have included treatments such as statins, non-calcium-based phosphate binders and cinacalcet. So far, the non-calcium-based phosphate binders showed significant benefit on mortality but none of the studies manifested a solid beneficial effect on vascular calcifications.
In the last years, remarkable data emerged concerning the association between vascular calcifications and plasmatic levels of dephosphorylated-undercarboxylated MGP (dp-ucMGP). dp-ucMGP is the inactive form of Matrix gla protein (MGP). MG
Sponsor: Saint-Joseph University
Current Primary Outcome: Rate of decrease of dp-ucMGP after daily supplementation with menaquinone [ Time Frame: Baseline-Four weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Saint-Joseph University
Dates:
Date Received: August 11, 2016
Date Started: August 2016
Date Completion:
Last Updated: September 18, 2016
Last Verified: September 2016
