Six months vitamin K treatment does not affect systemic arterial calcification or bone mineral density in diabetes mellitus 2
PURPOSE: Vitamin K-dependent proteins are involved in (patho)physiological calcification of the vasculature and the bones. Type 2 diabetes mellitus (DM2) is associated with increased arterial calcification and increased fractures. This study investigates the effect of 6 months vitamin K2 supplementation on systemic arterial calcification and bone mineral density (BMD) in DM2 patients with a history of cardiovascular disease (CVD).
METHODS: In this pre-specified, post hoc analysis of a double-blind, randomized, controlled clinical trial, patients with DM2 and CVD were randomized to a daily, oral dose of 360 µg vitamin K2 or placebo for 6 months. CT scans were made at baseline and follow-up. Arterial calcification mass was quantified in several large arterial beds and a total arterial calcification mass score was calculated. BMD was assessed in all non-fractured thoracic and lumbar vertebrae.
RESULTS: 68 participants were randomized, 35 to vitamin K2 (33 completed follow-up) and 33 to placebo (27 completed follow-up). The vitamin K group had higher arterial calcification mass at baseline [median (IQR): 1694 (812-3584) vs 1182 (235-2445)] for the total arterial calcification mass). Six months vitamin K supplementation did not reduce arterial calcification progression (β [95% CI]: - 0.02 [- 0.10; 0.06] for the total arterial calcification mass) or slow BMD decline (β [95% CI]: - 2.06 [- 11.26; 7.30] Hounsfield units for all vertebrae) when compared to placebo.
CONCLUSION: Six months vitamin K supplementation did not halt progression of arterial calcification or decline of BMD in patients with DM2 and CVD. Future clinical trials may want to pre-select patients with very low vitamin K status and longer follow-up time might be warranted. This trial was registered at clinicaltrials.gov as NCT02839044.
| Errataetall: |
CommentIn: Eur J Nutr. 2021 Apr;60(3):1701-1702. - PMID 33532875 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:60 |
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| Enthalten in: |
European journal of nutrition - 60(2021), 3 vom: 17. Apr., Seite 1691-1699 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Bartstra, Jonas W [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 23.06.2021 Date Revised 16.07.2022 published: Print-Electronic ClinicalTrials.gov: NCT02839044 CommentIn: Eur J Nutr. 2021 Apr;60(3):1701-1702. - PMID 33532875 Citation Status MEDLINE |
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| doi: |
10.1007/s00394-020-02412-z |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM316375993 |
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| 100 | 1 | |a Bartstra, Jonas W |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Six months vitamin K treatment does not affect systemic arterial calcification or bone mineral density in diabetes mellitus 2 |
| 264 | 1 | |c 2021 | |
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| 500 | |a Date Revised 16.07.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02839044 | ||
| 500 | |a CommentIn: Eur J Nutr. 2021 Apr;60(3):1701-1702. - PMID 33532875 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a PURPOSE: Vitamin K-dependent proteins are involved in (patho)physiological calcification of the vasculature and the bones. Type 2 diabetes mellitus (DM2) is associated with increased arterial calcification and increased fractures. This study investigates the effect of 6 months vitamin K2 supplementation on systemic arterial calcification and bone mineral density (BMD) in DM2 patients with a history of cardiovascular disease (CVD) | ||
| 520 | |a METHODS: In this pre-specified, post hoc analysis of a double-blind, randomized, controlled clinical trial, patients with DM2 and CVD were randomized to a daily, oral dose of 360 µg vitamin K2 or placebo for 6 months. CT scans were made at baseline and follow-up. Arterial calcification mass was quantified in several large arterial beds and a total arterial calcification mass score was calculated. BMD was assessed in all non-fractured thoracic and lumbar vertebrae | ||
| 520 | |a RESULTS: 68 participants were randomized, 35 to vitamin K2 (33 completed follow-up) and 33 to placebo (27 completed follow-up). The vitamin K group had higher arterial calcification mass at baseline [median (IQR): 1694 (812-3584) vs 1182 (235-2445)] for the total arterial calcification mass). Six months vitamin K supplementation did not reduce arterial calcification progression (β [95% CI]: - 0.02 [- 0.10; 0.06] for the total arterial calcification mass) or slow BMD decline (β [95% CI]: - 2.06 [- 11.26; 7.30] Hounsfield units for all vertebrae) when compared to placebo | ||
| 520 | |a CONCLUSION: Six months vitamin K supplementation did not halt progression of arterial calcification or decline of BMD in patients with DM2 and CVD. Future clinical trials may want to pre-select patients with very low vitamin K status and longer follow-up time might be warranted. This trial was registered at clinicaltrials.gov as NCT02839044 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Arterial calcification | |
| 650 | 4 | |a Bone mineral density | |
| 650 | 4 | |a Cardiovascular disease | |
| 650 | 4 | |a Randomized controlled clinical trial | |
| 650 | 4 | |a Type 2 diabetes | |
| 650 | 4 | |a Vitamin K | |
| 650 | 7 | |a Vitamin K 2 |2 NLM | |
| 650 | 7 | |a 11032-49-8 |2 NLM | |
| 650 | 7 | |a Vitamin K |2 NLM | |
| 650 | 7 | |a 12001-79-5 |2 NLM | |
| 700 | 1 | |a Draaisma, Fieke |e verfasserin |4 aut | |
| 700 | 1 | |a Zwakenberg, Sabine R |e verfasserin |4 aut | |
| 700 | 1 | |a Lessmann, Nikolas |e verfasserin |4 aut | |
| 700 | 1 | |a Wolterink, Jelmer M |e verfasserin |4 aut | |
| 700 | 1 | |a van der Schouw, Yvonne T |e verfasserin |4 aut | |
| 700 | 1 | |a de Jong, Pim A |e verfasserin |4 aut | |
| 700 | 1 | |a Beulens, Joline W J |e verfasserin |4 aut | |
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