NCT02839044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 2, 2019

Status Verified

September 1, 2019

Enrollment Period

2.3 years

First QC Date

July 18, 2016

Last Update Submit

September 30, 2019

Conditions

Arterial CalcificationDiabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Vitamin K

EXPERIMENTAL

One group receives tablets of 360 microgram menaquinone-7 daily

Dietary Supplement: Menaquinone-7

Placebo

PLACEBO COMPARATOR

One group receives placebo tablets daily

Dietary Supplement: Placebo

Interventions

Menaquinone-7DIETARY_SUPPLEMENT
Vitamin K
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Utrecht

Utrecht, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 31387121BACKGROUND

  • 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.

    PMID: 33068157DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

menaquinone 7

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

July 18, 2016

First Posted

July 20, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

October 2, 2019

Record last verified: 2019-09

Locations

NL(1)