Evidence map›Paper›PMID 31387121›Full record

Trial reportThe American journal of clinical nutrition2019

The effect of menaquinone-7 supplementation on vascular calcification in patients with diabetes: a randomized, double-blind, placebo-controlled trial.

S R Zwakenberg, P A de Jong, J W Bartstra, R van Asperen, J Westerink, H de Valk, R H J A Slart, G Luurtsema, J M Wolterink, G J de Borst and 5 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The American journal of clinical nutrition, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02839044 (A Randomized, Placebo-controlled, Double Blind Trial to Investigate Whether Vitamin K2 Can Influence Arterial Calcification in Patients With Type 2 Diabetes), which is not on this map. Cited by 47 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 3 pooled it
8.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02839044 nacompletednot on this map

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

TypeinterventionalSponsorUMC UtrechtRan2016 to 2018Enrolled68ConditionsArterial Calcification, Diabetes Mellitus Type 2ArmsMenaquinone-7, Placebo
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 3 syntheses or guidelines pooled it, 81 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. The effect of Vitamin-KJournal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology · 2022
    Trial
  5. Trial
  6. Vascular uptake onJournal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology · 2021
    Trial
  7. Trial
  8. Trial
  9. Trial
  10. Review
  11. Review
  12. Review
  13. Review
  14. Metabolic Engineering Strategy forFoods (Basel, Switzerland) · 2025
    Review
  15. Article
  16. Vitamin K and women's health: a review.Frontiers in global women's health · 2025
    Review
  17. Article
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 4 institutions in 1 country.

S R ZwakenbergJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
P A de JongDepartment of Radiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
J W BartstraDepartment of Radiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
R van AsperenJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
J WesterinkDepartment of Vascular Medicine, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
H de ValkDepartment of Endocrinology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
R H J A SlartMedical Imaging Center, Department of Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
G LuurtsemaMedical Imaging Center, Department of Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
J M WolterinkImage Sciences Institute, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
G J de BorstDepartment of Vascular Surgery, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
J A van HerwaardenDepartment of Vascular Surgery, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
M A van de ReeDepartment of Internal Medicine, Diakonessenhuis, Utrecht, Netherlands.
L J SchurgersDepartment of Biochemistry, Cardiovascular Research Institute Maastricht, Maastricht University, Maastricht, Netherlands.
Y T van der SchouwJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
J W J BeulensJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
Utrecht University · NLUniversity Medical Center Groningen · NLDiakonessenhuis hospital · NLMaastricht University · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVitamin K occurs in the diet as phylloquinone and menaquinones. Observational studies have shown that both phylloquinone and menaquinone intake might reduce cardiovascular disease (CVD) risk. However, the effect of vitamin K on vascular calcification is unknown.

objectivesThe aim of this study was to assess if menaquinone supplementation, compared to placebo, decreases vascular calcification in people with type 2 diabetes and known CVD.

methodsIn this double-blind, randomized, placebo-controlled trial, we randomly assigned men and women with type 2 diabetes and CVD to 360 µg/d menaquinone-7 (MK-7) or placebo for 6 mo. Femoral arterial calcification at baseline and 6 mo was measured with 18sodium fluoride positron emission tomography (18F-NaF PET) scans as target-to-background ratios (TBRs), a promising technique to detect active calcification. Calcification mass on conventional computed tomography (CT) scan was measured as secondary outcome. Dephosphorylated-uncarboxylated matrix Gla protein (dp-ucMGP) concentrations were measured to assess compliance. Linear regression analyses were performed with either TBR or CT calcification at follow-up as the dependent variable, and treatment and baseline TBR or CT calcification as independent variables.

resultsWe randomly assigned 35 patients to the MK-7 group (33 completed follow-up) and 33 to the placebo group (27 completed follow-up). After the 6-mo intervention, TBR tended to increase in the MK-7 group compared with placebo (0.25; 95% CI: -0.02, 0.51; P = 0.06), although this was not significant. Log-transformed CT calcification mass did not increase in the intervention group compared with placebo (0.50; 95% CI: -0.23, 1.36; P = 0.18). MK-7 supplementation significantly reduced dp-ucMGP compared with placebo (-205.6 pmol/L; 95% CI: -255.8, -155.3 pmol/L). No adverse events were reported.

conclusionMK-7 supplementation tended to increase active calcification measured with 18F-NaF PET activity compared with placebo, but no effect was found on conventional CT. Additional research investigating the interpretation of 18F-NaF PET activity is necessary. This trial was registered at clinicaltrials.gov as NCT02839044.

Indexed as

AgedDiabetes Mellitus, Type 2Dietary SupplementsDouble-Blind MethodFemaleHumansMaleMiddle AgedVascular CalcificationVitamin K 2menaquinone 7Vitamin K 2cardiovascular diseasediabetesmenaquinone-7vascular calcificationvitamin K

Identifiers

PMID31387121
PMCPMC6766434
OpenAlexW2964792265

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.