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

Not Applicable

Completed

• Conditions: Arterial Calcification; Diabetes Mellitus Type 2
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Menaquinone-7

• Registration Number: NCT02839044
• Lead Sponsor: UMC Utrecht

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-20
• Primary Completion: 2018-09
• Study Completion: 2018-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	One group receives placebo tablets daily
Vitamin K	Menaquinone-7	One group receives tablets of 360 microgram menaquinone-7 daily

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands