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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Arterial Calcification Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin K

One group receives tablets of 360 microgram menaquinone-7 daily

Group Type EXPERIMENTAL

Menaquinone-7

Intervention Type DIETARY_SUPPLEMENT

Placebo

One group receives placebo tablets daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Menaquinone-7

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No