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The effects of two vitamin K-forms on carboxylation of the vitamin K-dependent proteins osteocalcin and matrix-gla protein will be compared after supplementing these vitamins in a nutritional dose range.
The investigators hypothesized that MK-7 is more effective than K1 at a dose comparable to the RDA of vitamin K.
Vitamin K is a group name for the naturally occurring phylloquinone (K1) and menaquinones (MK-n; K2). The latter can be subdivided into the short-chain (e.g. MK-4) and the long-chain (e.g. MK-7, MK-8, and MK-9) menaquinones. Earlier studies have shown that high vitamin K intake leads to improved bone and vascular health by increased carboxylation of vitamin K-dependent proteins in these tissues. In the dietary range, MK-7 has been suggested to be the most effective cofactor for the carboxylation of Gla-proteins, such as osteocalcin (OC) and matrix-Gla protein (MGP).Until now, no randomized controlled trial has compared the efficacy of K1 versus MK-7 in a nutritional dose range. The investigators are therefore interested to compare the effects of K1 and MK-7 on OC and MGP carboxylation after supplementing these vitamins at a dose not exceeding the RDA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin K1 capsules | Active Comparator | 27 participants received for three months 1 vitamin K1-capsule per day containing 52 µg of K1 |
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| Vitamin K2-capsules | Active Comparator | 27 participants received for three months 1 vitamin K2-capsule per day containing 75 µg of MK-7. |
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| Placebo capsules | Placebo Comparator | 27 participants received for 3 months 1 placebo capsule per day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | 27 participants received for three months 1 placebo capsule per day |
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| Measure | Description | Time Frame |
|---|---|---|
| carboxylation of osteocalcin | The primary objective of the study is to compare the effects of K1 and MK-7 on circulating ucOC levels after supplementing these vitamins at a nutritional dose. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| carboxylation of matrix-gla protein | The secondary objective of the study is to compare the effects of K1 and MK-7 on circulating ucMGP, which is emerging as a biomarker of arterial calcification. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cees Vermeer, PhD | VitaK BV Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VitaK BV / Maastricht University Medicial Center | Maastricht | Netherlands |
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| Vitamin K1-capsules | Dietary Supplement | 27 participants received for 3 months 1 vitamin K1-capsule per day containing 52 µg of K1/day |
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| Vitamin K2-capsules | Dietary Supplement | 27 participants received for 3 months 1 vitamin K2-capsule per day containing 75 µg of MK-7. |
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