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

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ClinicalTrials.gov Identifier: NCT02839044
Recruitment Status : Active, not recruiting
First Posted : July 20, 2016
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Yvonne T. van der Schouw, 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.


Condition or disease Intervention/treatment Phase
Arterial Calcification Diabetes Mellitus Type 2 Dietary Supplement: Menaquinone-7 Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Double Blind Trial to Investigate Whether Vitamin K2 Can Influence Arterial Calcification in Patients With Type 2 Diabetes
Actual Study Start Date : June 2016
Actual Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals Vitamin K
Drug Information available for: Menadione

Arm Intervention/treatment
Experimental: Vitamin K
One group receives tablets of 360 microgram menaquinone-7 daily
Dietary Supplement: Menaquinone-7
Placebo Comparator: Placebo
One group receives placebo tablets daily
Dietary Supplement: Placebo



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839044


Locations
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Netherlands
UMC Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
UMC Utrecht

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yvonne T. van der Schouw, Prof., UMC Utrecht
ClinicalTrials.gov Identifier: NCT02839044     History of Changes
Other Study ID Numbers: 15/571
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Arteriosclerosis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Calcinosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Calcium Metabolism Disorders
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Vitamins
Vitamin K
Vitamin K 2
Vitamin MK 7
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants