Back to resultsA Randomized, Placebo-controlled, Double Blind Trial to Investigate Whether Vitamin K2 Can Influence Arterial Calcification in Patients With Type 2 Diabetes (Vitacal)
Primary Purpose
Arterial Calcification, Diabetes Mellitus Type 2
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Menaquinone-7
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Arterial Calcification
Eligibility 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).
Sites / Locations
- UMC Utrecht
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin K
Placebo
Arm Description
One group receives tablets of 360 microgram menaquinone-7 daily
One group receives placebo tablets daily
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02839044
Brief Title
A Randomized, Placebo-controlled, Double Blind Trial to Investigate Whether Vitamin K2 Can Influence Arterial Calcification in Patients With Type 2 Diabetes
Acronym
Vitacal
Official Title
A Randomized, Placebo-controlled, Double Blind Trial to Investigate Whether Vitamin K2 Can Influence Arterial Calcification in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Calcification, Diabetes Mellitus Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin K
Arm Type
Experimental
Arm Description
One group receives tablets of 360 microgram menaquinone-7 daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One group receives placebo tablets daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Menaquinone-7
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
31387121
Citation
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.
Results Reference
background
PubMed Identifier
33068157
Citation
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.
Results Reference
derived
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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
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