Risk Factors for Vascular Calcifications in Hemodialysis Patients: to What Extent is Vitamin K2 Deficiency Involved?
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|ClinicalTrials.gov Identifier: NCT02876354|
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : September 20, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Vascular Calcifications||Drug: Menaquinone||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Risk Factors for Vascular Calcifications in Hemodialysis Patients: to What Extent is Vitamin K2 Deficiency Involved?|
|Study Start Date :||August 2016|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Experimental: Menaquinone 360
All patients in the study will be assigned to receive menaquinone 360 μg /d for 4 weeks.
Patients on hemodialysis will be supplemented by 360 μg /d of menaquinone for 4 weeks. At baseline they will have a lateral abdominal X-Ray and dosage of dp-ucMGP. At the end of the study patients will have a second measurement of dp-ucMGP levels.
Other Name: Vitamin k2
- Rate of decrease of dp-ucMGP after daily supplementation with menaquinone [ Time Frame: Baseline-Four weeks ]We will analyze whether the percentage of decrease of dp-ucMGP in our Middle-Eastern country following vitamin k2 supplementation is similar to that reported in the previous trials in Europe.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876354
|Ajaltoun, Keserwan, Lebanon|
|Principal Investigator:||Mabel Aoun, MD||Université Saint-Joseph, Beirut, Lebanon|