A Randomized, Placebo-controlled, Double Blind Trial to Investigate Whether Vitamin K2 Can Influence Arterial Calcification in Patients With Type 2 Diabetes (Vitacal)

UMC Utrecht

Status

Completed

Conditions

Arterial Calcification

Diabetes Mellitus Type 2

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Menaquinone-7

Study type

Interventional

Funder types

Other

Identifiers

NCT02839044

15/571

Details and patient eligibility

About

Arterial calcification is an independent predictor of coronary events associated with a 3-4 fold increased risk of cardiovascular events. Currently, no effective intervention exists to reduce arterial calcification. However, recent studies showed that vitamin K may reduce ongoing calcium deposition in the arteries, and thereby inhibit arterial calcification.

The primary objective is to determine if MK-7 supplementation leads to stabilization or attenuation of ongoing calcium deposition in the femoral artery as quantified by 18F-NaF PET/CT imaging in patients with type 2 diabetes and arterial disease.

Enrollment

68 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Middle aged men and women, ≥ 40 years.
Diagnosed with type 2 diabetes.
Presence of arterial diseases, based on an Ankle Brachial Index (ABI) <0.9 and/or diagnosed with arterial diseases by physician.
ABI<0.9
Written informed consent.

Exclusion criteria

Subjects participate in another intervention research or study using imaging.
Contra-indication for undergoing18F-NaF PET/CT scan (claustrophobia, pregnancy, breastfeeding).
Subject underwent amputation of the lower extremities (above the knee).
Using vitamin K antagonists.
Known coagulation problems (history of Venous Thrombo Embolism).
Using vitamin supplements that contain vitamin K, or unwilling to stop two weeks before randomisation.
A mean vitamin K2 intake ≥120 microgram/day measured with a questionnaire.
Natto or goose liver consumers.
Low kidney function (eGFR<30).