Skip to main content
OpenTrials
Completed

NCT Number: NCT02839044

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arterial Calcification Diabetes Mellitus Diabetes Mellitus Type 2 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMC Utrecht

Utrecht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

menaquinone-7

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. 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.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Acronym: Vitacal

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 20, 2016
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.