No Detectable Coagulation Activation After Vitamin K (MK-7) Supplementation in Patients on Dialysis With Functional Vitamin K Deficiency: A One-Year Randomized, Placebo-Controlled Study
Patients on dialysis treatment have poor functional vitamin K status, and this may increase the risk of vascular calcification. Vitamin K supplementation may therefore be relevant in patients on dialysis, but the procoagulant effects have not been studied. We evaluated effects of menaquinone-7 (MK-7...
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| Veröffentlicht in: | Journal of renal nutrition 2024-07, Vol.34 (4), p.337-342 |
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| creator | Bladbjerg, Else-Marie Levy-Schousboe, Karin Frimodt-Møller, Marie Kjærgaard, Krista D. Strandhave, Charlotte Brasen, Claus L. Frandsen, Niels Erik Hansen, Ditte Marckmann, Peter |
| description | Patients on dialysis treatment have poor functional vitamin K status, and this may increase the risk of vascular calcification. Vitamin K supplementation may therefore be relevant in patients on dialysis, but the procoagulant effects have not been studied. We evaluated effects of menaquinone-7 (MK-7) supplementation on biomarkers of coagulation in patients on dialysis.
Double-blinded, placebo-controlled study in 123 patients on dialysis randomized to 52 weeks of vitamin K (MK-7, 360 μg/daily, n = 61) or placebo (n = 62). Measurements at baseline and after 52 weeks of intervention included thrombin generation (endogenous thrombin potential, peak thrombin concentration, time to peak, and lag time); clot activities of vitamin K-dependent coagulation factors (F) II, VII, IX, and X; prothrombin fragment 1 + 2 (F1+2); and proteins induced by vitamin K absence II (PIVKA-II). Between-group differences (vitamin K vs. placebo) at 52 weeks were determined with an analysis of covariance. Within-group changes in vitamin K and placebo groups were analyzed with a paired t-test. Vascular adverse events and serious adverse events were registered based on hospital records, laboratory data, and participant interviews and compared between groups using Fisher’s exact test or Pearson’s Chi-Squared test.
A between-group difference at 52 weeks was observed for PIVKA-II (P |
| doi_str_mv | 10.1053/j.jrn.2023.11.007 |
| format | Article |
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Double-blinded, placebo-controlled study in 123 patients on dialysis randomized to 52 weeks of vitamin K (MK-7, 360 μg/daily, n = 61) or placebo (n = 62). Measurements at baseline and after 52 weeks of intervention included thrombin generation (endogenous thrombin potential, peak thrombin concentration, time to peak, and lag time); clot activities of vitamin K-dependent coagulation factors (F) II, VII, IX, and X; prothrombin fragment 1 + 2 (F1+2); and proteins induced by vitamin K absence II (PIVKA-II). Between-group differences (vitamin K vs. placebo) at 52 weeks were determined with an analysis of covariance. Within-group changes in vitamin K and placebo groups were analyzed with a paired t-test. Vascular adverse events and serious adverse events were registered based on hospital records, laboratory data, and participant interviews and compared between groups using Fisher’s exact test or Pearson’s Chi-Squared test.
A between-group difference at 52 weeks was observed for PIVKA-II (P < .001). PIVKA-II decreased significantly from baseline to 52 weeks in the vitamin K group, but not in the placebo group. We observed no between-group differences or within-group changes for biomarkers of coagulation, except for FVII clot activity which was reduced in the placebo group (P = .04), and no between-group differences in adverse events and serious adverse events.
One year of vitamin K supplementation in patients on dialysis has no detectable effects on biomarkers of coagulation activation, clot activities of vitamin K-dependent coagulation factors, and vascular events or death, indicating no procoagulant effects of this treatment.</description><identifier>ISSN: 1051-2276</identifier><identifier>ISSN: 1532-8503</identifier><identifier>EISSN: 1532-8503</identifier><identifier>DOI: 10.1053/j.jrn.2023.11.007</identifier><identifier>PMID: 38128853</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Biomarkers ; chronic kidney disease ; dialysis ; menaquione-7 ; thrombin generation ; thrombosis</subject><ispartof>Journal of renal nutrition, 2024-07, Vol.34 (4), p.337-342</ispartof><rights>2023 National Kidney Foundation, Inc.</rights><rights>Copyright © 2023. Published by Elsevier Inc.</rights><rights>Copyright © 2023 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c353t-9e8fe8fdb85e41d7f48a5ff7d138862e9d155c3af21928feb4dfb07aa16a6b7e3</citedby><cites>FETCH-LOGICAL-c353t-9e8fe8fdb85e41d7f48a5ff7d138862e9d155c3af21928feb4dfb07aa16a6b7e3</cites><orcidid>0000-0001-8654-2449 ; 0000-0002-5828-5382 ; 0000-0002-7458-8172 ; 0000-0002-8486-1515 ; 0000-0003-4929-7901 ; 0000-0003-0912-2437 ; 0000-0003-4584-6723</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1053/j.jrn.2023.11.007$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38128853$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bladbjerg, Else-Marie</creatorcontrib><creatorcontrib>Levy-Schousboe, Karin</creatorcontrib><creatorcontrib>Frimodt-Møller, Marie</creatorcontrib><creatorcontrib>Kjærgaard, Krista D.</creatorcontrib><creatorcontrib>Strandhave, Charlotte</creatorcontrib><creatorcontrib>Brasen, Claus L.</creatorcontrib><creatorcontrib>Frandsen, Niels Erik</creatorcontrib><creatorcontrib>Hansen, Ditte</creatorcontrib><creatorcontrib>Marckmann, Peter</creatorcontrib><title>No Detectable Coagulation Activation After Vitamin K (MK-7) Supplementation in Patients on Dialysis With Functional Vitamin K Deficiency: A One-Year Randomized, Placebo-Controlled Study</title><title>Journal of renal nutrition</title><addtitle>J Ren Nutr</addtitle><description>Patients on dialysis treatment have poor functional vitamin K status, and this may increase the risk of vascular calcification. Vitamin K supplementation may therefore be relevant in patients on dialysis, but the procoagulant effects have not been studied. We evaluated effects of menaquinone-7 (MK-7) supplementation on biomarkers of coagulation in patients on dialysis.
Double-blinded, placebo-controlled study in 123 patients on dialysis randomized to 52 weeks of vitamin K (MK-7, 360 μg/daily, n = 61) or placebo (n = 62). Measurements at baseline and after 52 weeks of intervention included thrombin generation (endogenous thrombin potential, peak thrombin concentration, time to peak, and lag time); clot activities of vitamin K-dependent coagulation factors (F) II, VII, IX, and X; prothrombin fragment 1 + 2 (F1+2); and proteins induced by vitamin K absence II (PIVKA-II). Between-group differences (vitamin K vs. placebo) at 52 weeks were determined with an analysis of covariance. Within-group changes in vitamin K and placebo groups were analyzed with a paired t-test. Vascular adverse events and serious adverse events were registered based on hospital records, laboratory data, and participant interviews and compared between groups using Fisher’s exact test or Pearson’s Chi-Squared test.
A between-group difference at 52 weeks was observed for PIVKA-II (P < .001). PIVKA-II decreased significantly from baseline to 52 weeks in the vitamin K group, but not in the placebo group. We observed no between-group differences or within-group changes for biomarkers of coagulation, except for FVII clot activity which was reduced in the placebo group (P = .04), and no between-group differences in adverse events and serious adverse events.
One year of vitamin K supplementation in patients on dialysis has no detectable effects on biomarkers of coagulation activation, clot activities of vitamin K-dependent coagulation factors, and vascular events or death, indicating no procoagulant effects of this treatment.</description><subject>Biomarkers</subject><subject>chronic kidney disease</subject><subject>dialysis</subject><subject>menaquione-7</subject><subject>thrombin generation</subject><subject>thrombosis</subject><issn>1051-2276</issn><issn>1532-8503</issn><issn>1532-8503</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNp9kc1uEzEUhUcIREvhAdggL4vEDP4ZZxy6ihIKqIVWlB-xsjz2NTjyjIPtqRTejLfDIQGxQrLkc-XvHOn6VNVjghuCOXu-btZxbCimrCGkwbi7Ux0TzmgtOGZ3i8ac1JR2s6PqQUprjAnhgt6vjpggVAjOjquf7wJaQQadVe8BLYP6OnmVXRjRQmd3e5A2Q0SfXFaDG9EFOn17UXdP0c202XgYYMx7rLxdF1XmhMq4cspvk0vos8vf0Pk06h2l_D9BK7BOF4PevkALdDVC_QVURO_VaMLgfoB5hq690tCHehnGHIP3YNBNnsz2YXXPKp_g0eE-qT6ev_ywfF1fXr16s1xc1ppxlus5CFuO6QWHlpjOtkJxaztDmBAzCnNDONdMWUrmtKB9a2yPO6XITM36DthJdbrP3cTwfYKU5eCSBu_VCGFKks4x57SdibagZI_qGFKKYOUmukHFrSRY7hqTa1kak7vGJCGyNFY8Tw7xUz-A-ev4U1EBzvYAlCVvHUSZfv8YGBdLbdIE95_4XzktqUI</recordid><startdate>20240701</startdate><enddate>20240701</enddate><creator>Bladbjerg, Else-Marie</creator><creator>Levy-Schousboe, Karin</creator><creator>Frimodt-Møller, Marie</creator><creator>Kjærgaard, Krista D.</creator><creator>Strandhave, Charlotte</creator><creator>Brasen, Claus L.</creator><creator>Frandsen, Niels Erik</creator><creator>Hansen, Ditte</creator><creator>Marckmann, Peter</creator><general>Elsevier Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-8654-2449</orcidid><orcidid>https://orcid.org/0000-0002-5828-5382</orcidid><orcidid>https://orcid.org/0000-0002-7458-8172</orcidid><orcidid>https://orcid.org/0000-0002-8486-1515</orcidid><orcidid>https://orcid.org/0000-0003-4929-7901</orcidid><orcidid>https://orcid.org/0000-0003-0912-2437</orcidid><orcidid>https://orcid.org/0000-0003-4584-6723</orcidid></search><sort><creationdate>20240701</creationdate><title>No Detectable Coagulation Activation After Vitamin K (MK-7) Supplementation in Patients on Dialysis With Functional Vitamin K Deficiency: A One-Year Randomized, Placebo-Controlled Study</title><author>Bladbjerg, Else-Marie ; Levy-Schousboe, Karin ; Frimodt-Møller, Marie ; Kjærgaard, Krista D. ; Strandhave, Charlotte ; Brasen, Claus L. ; Frandsen, Niels Erik ; Hansen, Ditte ; Marckmann, Peter</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c353t-9e8fe8fdb85e41d7f48a5ff7d138862e9d155c3af21928feb4dfb07aa16a6b7e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Biomarkers</topic><topic>chronic kidney disease</topic><topic>dialysis</topic><topic>menaquione-7</topic><topic>thrombin generation</topic><topic>thrombosis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bladbjerg, Else-Marie</creatorcontrib><creatorcontrib>Levy-Schousboe, Karin</creatorcontrib><creatorcontrib>Frimodt-Møller, Marie</creatorcontrib><creatorcontrib>Kjærgaard, Krista D.</creatorcontrib><creatorcontrib>Strandhave, Charlotte</creatorcontrib><creatorcontrib>Brasen, Claus L.</creatorcontrib><creatorcontrib>Frandsen, Niels Erik</creatorcontrib><creatorcontrib>Hansen, Ditte</creatorcontrib><creatorcontrib>Marckmann, Peter</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of renal nutrition</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bladbjerg, Else-Marie</au><au>Levy-Schousboe, Karin</au><au>Frimodt-Møller, Marie</au><au>Kjærgaard, Krista D.</au><au>Strandhave, Charlotte</au><au>Brasen, Claus L.</au><au>Frandsen, Niels Erik</au><au>Hansen, Ditte</au><au>Marckmann, Peter</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>No Detectable Coagulation Activation After Vitamin K (MK-7) Supplementation in Patients on Dialysis With Functional Vitamin K Deficiency: A One-Year Randomized, Placebo-Controlled Study</atitle><jtitle>Journal of renal nutrition</jtitle><addtitle>J Ren Nutr</addtitle><date>2024-07-01</date><risdate>2024</risdate><volume>34</volume><issue>4</issue><spage>337</spage><epage>342</epage><pages>337-342</pages><issn>1051-2276</issn><issn>1532-8503</issn><eissn>1532-8503</eissn><abstract>Patients on dialysis treatment have poor functional vitamin K status, and this may increase the risk of vascular calcification. Vitamin K supplementation may therefore be relevant in patients on dialysis, but the procoagulant effects have not been studied. We evaluated effects of menaquinone-7 (MK-7) supplementation on biomarkers of coagulation in patients on dialysis.
Double-blinded, placebo-controlled study in 123 patients on dialysis randomized to 52 weeks of vitamin K (MK-7, 360 μg/daily, n = 61) or placebo (n = 62). Measurements at baseline and after 52 weeks of intervention included thrombin generation (endogenous thrombin potential, peak thrombin concentration, time to peak, and lag time); clot activities of vitamin K-dependent coagulation factors (F) II, VII, IX, and X; prothrombin fragment 1 + 2 (F1+2); and proteins induced by vitamin K absence II (PIVKA-II). Between-group differences (vitamin K vs. placebo) at 52 weeks were determined with an analysis of covariance. Within-group changes in vitamin K and placebo groups were analyzed with a paired t-test. Vascular adverse events and serious adverse events were registered based on hospital records, laboratory data, and participant interviews and compared between groups using Fisher’s exact test or Pearson’s Chi-Squared test.
A between-group difference at 52 weeks was observed for PIVKA-II (P < .001). PIVKA-II decreased significantly from baseline to 52 weeks in the vitamin K group, but not in the placebo group. We observed no between-group differences or within-group changes for biomarkers of coagulation, except for FVII clot activity which was reduced in the placebo group (P = .04), and no between-group differences in adverse events and serious adverse events.
One year of vitamin K supplementation in patients on dialysis has no detectable effects on biomarkers of coagulation activation, clot activities of vitamin K-dependent coagulation factors, and vascular events or death, indicating no procoagulant effects of this treatment.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>38128853</pmid><doi>10.1053/j.jrn.2023.11.007</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0001-8654-2449</orcidid><orcidid>https://orcid.org/0000-0002-5828-5382</orcidid><orcidid>https://orcid.org/0000-0002-7458-8172</orcidid><orcidid>https://orcid.org/0000-0002-8486-1515</orcidid><orcidid>https://orcid.org/0000-0003-4929-7901</orcidid><orcidid>https://orcid.org/0000-0003-0912-2437</orcidid><orcidid>https://orcid.org/0000-0003-4584-6723</orcidid></addata></record> |
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| subjects | Biomarkers chronic kidney disease dialysis menaquione-7 thrombin generation thrombosis |
| title | No Detectable Coagulation Activation After Vitamin K (MK-7) Supplementation in Patients on Dialysis With Functional Vitamin K Deficiency: A One-Year Randomized, Placebo-Controlled Study |
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