NCT01638182

Biocomparison Study

Comparison of Effects of Nutritional Doses Vitamin K1 and K2 on Carboxylation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Bone Health
• Vascular Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	27 participants received for three months 1 placebo capsule per day
DIETARY_SUPPLEMENT	Vitamin K1-capsules	27 participants received for 3 months 1 vitamin K1-capsule per day containing 52 µg of K1/day
DIETARY_SUPPLEMENT	Vitamin K2-capsules	27 participants received for 3 months 1 vitamin K2-capsule per day containing 75 µg of MK-7.

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-06-01
• Completion: 2011-09-01
• First posted: 2012-07-11
• Last updated: 2012-07-11

Locations

1 site across 1 country: Netherlands