|- candidate number||22327|
|- NTR Number||NTR5287|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-jun-2015|
|- Secondary IDs|| NL53572.041.15 ABR|
|- Public Title||Vitamin K and arterial calcification|
|- Scientific Title||A randomized, placebo-controlled, double blind trial to study the effects of vitamin K2 and arterial calcification in patients with type 2 diabetes|
|- hypothesis||We 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) studied||Vitamin K, Vascular calcification, Diabetes Mellitus, Bone Metabolism|
|- Inclusion criteria||- Middle aged men and women ¡Ý 40 years. |
- Diagnosed with type 2 diabetes.
- At high risk of arterial calcification, based on an Ankle Brachial Index (ABI) <0.9 or ¡Ý 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 ¡Ý 120 ¦Ìg/day measured with a telephone questionnaire.
- Natto or goose liver consumers.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2015|
|- planned closingdate||1-nov-2016|
|- Target number of participants||0|
|- Interventions||vitamin K2 (menaquinone-7) |
|- Primary outcome||Arterial 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.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Msc. Sabine Zwakenberg|
|- CONTACT for SCIENTIFIC QUERIES||Msc. Sabine Zwakenberg|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|Dutch Heart Foundation (Nederlandse Hartstichting)|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||10-jun-2015 - 19-aug-2015|