Evidence map›Paper›PMID 37451735›Full record

ArticleBMJ open2023

Effects of vitamins K2 and D3 supplementation in patients with severe coronary artery calcification: a study protocol for a randomised controlled trial.

Selma Hasific, Kristian A Øvrehus, Susanne Hosbond, Jess Lambrechtsen, Preman Kumarathurai, Anna Mejldal, Emil Johannes Ravn, Lars Melholt Rasmussen, Oke Gerke, Hans Mickley and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05500443 (The Effects of Menaquinone-7 Supplementation in Patients With Severe Coronary Calcifications), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 31% 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.

NCT05500443 nacompletednot on this map

The Effects of Menaquinone-7 Supplementation in Patients With Severe Coronary Calcifications

TypeinterventionalSponsorOdense University HospitalRan2023 to 2026Enrolled400ConditionsCoronary Artery DiseaseArmsVitamin K2 (Menaquinone-7)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. 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

11 authors at 4 institutions in 1 country.

Selma HasificDepartment of Cardiology, Odense University Hospital, Odense, Denmark.ORCID 0000-0001-7654-8492
Kristian A ØvrehusDepartment of Cardiology, Odense University Hospital, Odense, Denmark.
Susanne HosbondDepartment of Cardiology, Sygehus Lillebalt, Vejle, Syddanmark, Denmark.
Jess LambrechtsenDepartment of Cardiology, Svendborg Hospital, Svendborg, Denmark.
Preman KumarathuraiDepartment of Cardiology, Odense University Hospital, Odense, Denmark.
Anna MejldalDepartment of Clinical Research, University of Southern Denmark, Odense, Denmark.
Emil Johannes RavnDepartment of Cardiology, Odense University Hospital, Odense, Denmark.ORCID 0000-0002-8992-5493
Lars Melholt RasmussenDepartment of Clinical Biochemistry and Pharmacology, Odense Universitetshospital, Odense, Denmark.
Oke GerkeDepartment of Nuclear Medicine, Odense University Hospital, Odense, Denmark.ORCID 0000-0001-6335-3303
Hans MickleyDepartment of Cardiology, Odense University Hospital, Odense, Denmark.
Axel DiederichsenDepartment of Cardiology, Odense University Hospital, Odense, Denmark axel.diederichsen@rsyd.dk.ORCID 0000-0002-1285-4826
Odense University Hospital · DKSvendborg Sygehus · DKUniversity of Southern Denmark · DKVejle Sygehus · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCoronary artery calcification (CAC) and especially progression in CAC is a strong predictor of acute myocardial infarction and cardiovascular mortality. Supplementation with vitamin K2 and D3 has been suggested to have a protective role in the progression of CAC. In this study, we will examine the effect of vitamins K2 and D3 in men and women with severe CAC. We hypothesise that supplementation with vitamins K2 and D3 will slow down the calcification process. METHOD AND ANALYSIS: In this multicentre and double-blinded placebo-controlled study, 400 men and women with CAC score≥400 are randomised (1:1) to treatment with vitamin K2 (720 µg/day) and vitamin D3 (25 µg/day) or placebo treatment (no active treatment) for 2 years. Among exclusion criteria are treatment with vitamin K antagonist, coagulation disorders and prior coronary artery disease. To evaluate progression in coronary plaque, a cardiac CT-scan is performed at baseline and repeated after 12 and 24 months of follow-up. Primary outcome is progression in CAC score from baseline to follow-up at 2 years. Among secondary outcomes are coronary plaque composition and cardiac events. Intention-to-treat principle is used for all analyses. ETHICS AND DISSEMINATION: There are so far no reported adverse effects associated with the use of vitamin K2. The protocol was approved by the Regional Scientific Ethical Committee for Southern Denmark and the Data Protection Agency. It will be conducted in accordance with the Declaration of Helsinki. Positive as well as negative findings will be reported. TRIAL REGISTRATION NUMBER: NCT05500443.

Indexed as

CalcinosisCoronary Artery DiseaseDietary SupplementsDouble-Blind MethodFemaleHumansMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicVitamin K 2VitaminsVitamin K 2VitaminsCardiovascular imagingClinical TrialIschaemic heart diseaseNUTRITION & DIETETICSPREVENTIVE MEDICINE

Identifiers

PMID37451735
PMCPMC10351276
OpenAlexW4384344068

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.