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

Conditions

Arterial Calcification, Diabetes Mellitus Type 2

Brief summary

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.

Bartstra JW, Draaisma F, Zwakenberg SR, Lessmann N, Wolterink JM, van der Schouw YT, de Jong PA, Beulens JWJ.

2020-10-1721 citations

10.1007/s00394-020-02412-z

Determinants of <sup>18</sup>F-NaF uptake in femoral arteries in patients with type 2 diabetes mellitus.

Takx RAP, van Asperen R, Bartstra JW, Zwakenberg SR, Wolterink JM, Celeng C, de Jong PA, Beulens JW.

2020-03-1713 citations

10.1007/s12350-020-02099-z

The effect of menaquinone-7 supplementation on vascular calcification in patients with diabetes: a randomized, double-blind, placebo-controlled trial.

Zwakenberg SR, de Jong PA, Bartstra JW, van Asperen R, Westerink J, de Valk H, Slart RHJA, Luurtsema G, Wolterink JM, de Borst GJ, van Herwaarden JA, van de Ree MA, Schurgers LJ, van der Schouw YT, Beulens JWJ.

2019-10-0154 citations

10.1093/ajcn/nqz147

Interventions

DIETARY_SUPPLEMENTMenaquinone-7

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

No

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).

Design outcomes

Primary

Measure	Time frame
Absolute change in ongoing calcium deposition quantified as volumetric bone metabolic rate (CSUVMEAN x cm3) in the femoral artery between baseline and 6 months after baseline, as determined by 18F-NaF PET/CT imaging.	6 months

Countries

Netherlands

Outcome results

None listed