- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02839044
A Randomized, Placebo-controlled, Double Blind Trial to Investigate Whether Vitamin K2 Can Influence Arterial Calcification in Patients With Type 2 Diabetes (Vitacal)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Utrecht, Netherlands
- UMC Utrecht
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vitamin K
One group receives tablets of 360 microgram menaquinone-7 daily
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Placebo Comparator: Placebo
One group receives placebo tablets daily
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What is the study measuring?
Primary Outcome Measures
Outcome 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.
Time Frame: 6 months
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6 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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. The effect of menaquinone-7 supplementation on vascular calcification in patients with diabetes: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2019 Oct 1;110(4):883-890. doi: 10.1093/ajcn/nqz147.
- Bartstra JW, Draaisma F, Zwakenberg SR, Lessmann N, Wolterink JM, van der Schouw YT, de Jong PA, Beulens JWJ. Six months vitamin K treatment does not affect systemic arterial calcification or bone mineral density in diabetes mellitus 2. Eur J Nutr. 2021 Apr;60(3):1691-1699. doi: 10.1007/s00394-020-02412-z. Epub 2020 Oct 17.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Arterial Occlusive Diseases
- Endocrine System Diseases
- Calcium Metabolism Disorders
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Arteriosclerosis
- Calcinosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Fibrin Modulating Agents
- Micronutrients
- Vitamins
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Vitamin K
- Vitamin K 2
- Vitamin MK 7
Other Study ID Numbers
- 15/571
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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