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

Diabetes Mellitus Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02839044
• Other study ID #: 15/571
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2018

Study information

• Verified date: September 2019
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arterial Calcification
• Arteriosclerosis
• Calcinosis
• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• Menaquinone-7

• Placebo

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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 Aug 6. pii: nqz147. doi: 10.1093/ajcn/nqz147. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 months