Skip to content

Vitamin K and arterial calcification

A randomized, placebo-controlled, double blind trial to study the effects of vitamin K2 and arterial calcification in patients with type 2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25255
Enrollment
Unknown
Registered
2015-06-10
Start date
2015-10-01
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin K, menaquinone-7, arterial calcification, dp-ucMGP, diabetes patiënts, arterial stiffness, bone metabolism.

Interventions

Sponsors

UMC Utrecht
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Middle aged men and women ¡Ý 40 years. - Diagnosed with type 2 diabetes. - At high risk of arterial calcification, based on an Ankle Brachial Index (ABI) <0.9 or ¡Ý 1.3 or diagnosed PAD (prevalence is 24% in patients with type 2 diabetes (39)). - Written informed consent

Exclusion criteria

Exclusion criteria: - Contra-indication for undergoing 18F-NaF PET/CT scan (pregnancy, breastfeeding, recent radiotherapy or chemotherapy). - Subject underwent amputation. - Not willing to give up blood donation during the study. - Using vitamin K antagonists. - Known coagulation problems (history of thrombosis). - Using vitamin supplements that contain vitamin K, vitamin D or calcium. - A mean vitamin K2 intake ¡Ý 120 ¦Ìg/day measured with a telephone questionnaire. - Natto or goose liver consumers.

Design outcomes

Primary

MeasureTime frame
Arterial calcifications as quantified by 18F-NaF PET/CT imaging.

Secondary

MeasureTime frame
- Arterial calcification in other arteries than the femoral artery as quantified by 18F-NaF PET/CT imaging. - Bone metabolism in the lumbar spine, as quantified by 18F-NaF PET/CT imaging. - Arterial stiffness, as quantified by pulse wave velocity measurement. - Dpuc-MGP, as quantified using a sandwich ELISA.

Contacts

Public ContactSabine Zwakenberg

Julius Center for Health Sciences and Primary Care -Universitair Medisch Centrum Utrecht

S.R.Zwakenberg@umcutrecht.nl+31 (0)88 75 69631

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)