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van CCT (UK)

van CCT (UK)

Vitamin K and arterial calcification

- candidate number22327
- NTR NumberNTR5287
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-jun-2015
- Secondary IDs NL53572.041.15 ABR
- Public TitleVitamin K and arterial calcification
- Scientific TitleA randomized, placebo-controlled, double blind trial to study the effects of vitamin K2 and arterial calcification in patients with type 2 diabetes
- ACRONYMVitacal
- hypothesisWe expect that supplementation with vitamin K will attenuated or reduce ongoing calcification and will significantly reduce dp-ucMGP in patients with type 2 diabetes.
- Healt Condition(s) or Problem(s) studiedVitamin K, Vascular calcification, Diabetes Mellitus, Bone Metabolism
- Inclusion criteria- Middle aged men and women 40 years.
- Diagnosed with type 2 diabetes.
- At high risk of arterial calcification, based on an Ankle Brachial Index (ABI) <0.9 or 1.3 or diagnosed PAD (prevalence is 24% in patients with type 2 diabetes (39)).
- Written informed consent
- Exclusion criteria- Contra-indication for undergoing 18F-NaF PET/CT scan (pregnancy, breastfeeding, recent radiotherapy or chemotherapy).
- Subject underwent amputation.
- Not willing to give up blood donation during the study.
- Using vitamin K antagonists.
- Known coagulation problems (history of thrombosis).
- Using vitamin supplements that contain vitamin K, vitamin D or calcium.
- A mean vitamin K2 intake 120 g/day measured with a telephone questionnaire.
- Natto or goose liver consumers.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2015
- planned closingdate1-nov-2016
- Target number of participants0
- Interventionsvitamin K2 (menaquinone-7)
- Primary outcomeArterial calcifications as quantified by 18F-NaF PET/CT imaging.
- Secondary outcome- Arterial calcification in other arteries than the femoral artery as quantified by 18F-NaF PET/CT imaging.
- Bone metabolism in the lumbar spine, as quantified by 18F-NaF PET/CT imaging.
- Arterial stiffness, as quantified by pulse wave velocity measurement.
- Dpuc-MGP, as quantified using a sandwich ELISA.
- Timepoints
- Trial web site
- status[default]
- CONTACT for SCIENTIFIC QUERIESMsc. Sabine Zwakenberg
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Dutch Heart Foundation (Nederlandse Hartstichting)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD10-jun-2015 - 19-aug-2015

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