The ViKTORIES trial: A randomized, double-blind, placebo-controlled trial of vitamin K supplementation to improve vascular health in kidney transplant recipients

Lees et al., 2021 | Am J Transplant | Rct

Citation

Lees Jennifer S, Rankin Alastair J, ... Mark Patrick B. The ViKTORIES trial: A randomized, double-blind, placebo-controlled trial of vitamin K supplementation to improve vascular health in kidney transplant recipients. Am J Transplant. 2021-Oct;21(10):3356-3368. doi:10.1111/ajt.16566

Abstract

Premature cardiovascular disease and death with a functioning graft are leading causes of death and graft loss, respectively, in kidney transplant recipients (KTRs). Vascular stiffness and calcification are markers of cardiovascular disease that are prevalent in KTR and associated with subclinical vitamin K deficiency. We performed a single-center, phase II, parallel-group, randomized, double-blind, placebo-controlled trial (ISRCTN22012044) to test whether vitamin K supplementation reduced vascular stiffness (MRI-based aortic distensibility) or calcification (coronary artery calcium score on computed tomography) in KTR over 1 year of treatment. The primary outcome was between-group difference in vascular stiffness (ascending aortic distensibility). KTRs were recruited between September 2017 and June 2018, and randomized 1:1 to vitamin K (menadiol diphosphate 5 mg; n = 45) or placebo (n = 45) thrice weekly. Baseline demographics, clinical history, and immunosuppression regimens were similar between groups. There was no impact of vitamin K on vascular stiffness (treatment effect -0.23 [95% CI -0.75 to 0.29] × 10-3  mmHg-1 ; p = .377), vascular calcification (treatment effect -141 [95% CI - 320 to 38] units; p = .124), nor any other outcome measure. In this heterogeneous cohort of prevalent KTR, vitamin K supplementation did not reduce vascular stiffness or calcification over 1 year. Improving vascular health in KTR is likely to require a multifaceted approach.

Key Findings

Improving vascular health in KTR is likely to require a multifaceted approach.

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population See abstract
Sample Size 45
Age Range See abstract
Condition deficiency

MeSH Terms

  • Dietary Supplements
  • Double-Blind Method
  • Humans
  • Kidney Transplantation
  • Vascular Calcification
  • Vascular Stiffness
  • Vitamin K

Evidence Classification

  • Level: Rct
  • Publication Types: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
  • Vertical: vitamin-k-bone

Provenance


Source extracted via PubMed E-utilities API on 2026-04-09