Evidence map›Paper›PMID 35641194›Full record

Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2023

Inhibit progression of coronary artery calcification with vitamin K in hemodialysis patients (the iPACK-HD study): a randomized, placebo-controlled multi-center, pilot trial.

Rachel M Holden, Sarah L Booth, Deborah Zimmerman, Louise Moist, Patrick A Norman, Andrew G Day, Alex Menard, Xueyan Fu, M Kyla Shea, Corinne S Babiolakis and 6 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01528800 (Inhibit Progression of Coronary Artery Calcification With Vitamin K in HemoDialysis Patients), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
1.5field-weighted citation impact, top 20% 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.

NCT01528800 phase2completednot on this map

Inhibit Progression of Coronary Artery Calcification With Vitamin K in HemoDialysis Patients: The iPACK-HD Study

TypeinterventionalSponsorDr. Rachel HoldenRan2012 to 2019Enrolled85ConditionsEnd-stage Kidney DiseaseArmsVitamin K1, Microcrystalline Methylcellulose
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
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  5. Review
  6. Review
  7. Vitamin K and women's health: a review.Frontiers in global women's health · 2025
    Review
  8. Review
  9. Article
  10. Review
  11. Article
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

16 authors at 4 institutions in 2 countries.

Rachel M HoldenDepartment of Medicine, Queen's University, Kingston, Ontario, Canada.ORCID 0000-0001-6431-3127
Sarah L BoothJean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.
Deborah ZimmermanDepartment of Medicine, University of Ottawa, Ottawa, Ontario, Canada.ORCID 0000-0003-0000-8806
Louise MoistDepartment of Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
Patrick A NormanKingston General Health Research Institute, Kingston Health Sciences Center, Kingston, Ontario, Canada.
Andrew G DayKingston General Health Research Institute, Kingston Health Sciences Center, Kingston, Ontario, Canada.
Alex MenardDepartment of Radiology, Queen's University, Kingston, Ontario, Canada.
Xueyan FuJean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.
M Kyla SheaJean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.
Corinne S BabiolakisDepartment of Medicine, Queen's University, Kingston, Ontario, Canada.
Robert NolanDepartment of Radiology, Queen's University, Kingston, Ontario, Canada.
Mandy E TurnerDepartment of Biomedical and Molecular Science, Queen's University, Kingston, Ontario, Canada.
Emilie WardDepartment of Biomedical and Molecular Science, Queen's University, Kingston, Ontario, Canada.
Martin KaufmannDepartment of Biomedical and Molecular Science, Queen's University, Kingston, Ontario, Canada.
Michael A AdamsDepartment of Biomedical and Molecular Science, Queen's University, Kingston, Ontario, Canada.
Daren K HeylandDepartment of Public Health Sciences, Queen's University, Kingston, Ontario, Canada.
Queen's University · CATufts University · USUniversity of Ottawa · CAWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVitamin K activates matrix Gla protein (MGP), a key inhibitor of vascular calcification. There is a high prevalence of sub-clinical vitamin K deficiency in patients with end-stage kidney disease.

methodsA parallel randomized placebo-controlled pilot trial was designed to determine whether 10 mg of phylloquinone thrice weekly versus placebo modifies coronary artery calcification progression over 12 months in patients requiring hemodialysis with a coronary artery calcium score (CAC) ≥30 Agatston Units (ClinicalTrials.gov identifier NCT01528800). The primary outcome was feasibility (recruitment rate, compliance with study medication, study completion and adherence overall to study protocol). CAC score was used to assess calcification at baseline and 12 months. Secondary objectives were to explore the impact of phylloquinone on vitamin K-related biomarkers (phylloquinone, dephospho-uncarboxylated MGP and the Gla-osteocalcin to Glu-osteocalcin ratio) and events of clinical interest.

resultsA total of 86 patients with a CAC score ≥30 Agatston Units were randomized to either 10 mg of phylloquinone or a matching placebo three times per week. In all, 69 participants (80%) completed the trial. Recruitment rate (4.4 participants/month) and medication compliance (96%) met pre-defined feasibility criteria of ≥4.17 and ≥90%, respectively. Patients randomized to phylloquinone for 12 months had significantly reduced levels of dephospho-uncarboxylated MGP (86% reduction) and increased levels of phylloquinone and Gla-osteocalcin to Glu-osteocalcin ratio compared with placebo. There was no difference in the absolute or relative progression of coronary artery calcification between groups.

conclusionWe demonstrated that phylloquinone treatment improves vitamin K status and that a fully powered randomized trial may be feasible.

Indexed as

Coronary Artery DiseaseVascular CalcificationCalcium-Binding ProteinsExtracellular Matrix ProteinsHumansOsteocalcinPilot ProjectsRenal DialysisVitamin KVitamin K 1Vitamin K 2Calcium-Binding ProteinsExtracellular Matrix ProteinsOsteocalcinVitamin KVitamin K 1Vitamin K 2chronic kidney diseasecoronary artery calcificationphylloquinonerandomized pilotvitamin K

Identifiers

PMID35641194
PMCPMC9976736
OpenAlexW4282920520

What OpenQuestion holds

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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.