Randomized trial of vitamin D versus placebo supplementation on markers of systemic inflammation in hypertensive patients

Nutr Metab Cardiovasc Dis. 2021 Oct 28;31(11):3202-3209. doi: 10.1016/j.numecd.2021.07.028. Epub 2021 Aug 18.

Abstract

Background and aims: Animal and cell models indicated that vitamin D modulates inflammatory activity, which is considered relevant in the pathogenesis of arterial hypertension and cardiovascular diseases. We therefore aimed to investigate the effect of vitamin D supplementation on systemic markers of inflammation in a cohort of hypertensive patients.

Methods and results: The Styrian Vitamin D Hypertension Trial is a single-centre, double-blind, placebo-controlled study conducted from 2011 to 2014 in Austria. We enrolled 200 study participants with arterial hypertension and 25-hydroxy-vitamin-D (25(OH)D) concentration below 30 ng/mL. Study participants were randomized to receive either 2800 IU of vitamin D3 per day or placebo for 8 weeks. The present investigation is a post-hoc analysis using analysis of co-variance (ANCOVA). Outcome measures were biomarkers of inflammation including CRP, leukocytes including subtypes and leukocyte-to-lymphocyte ratio, leucine and kynurenic acid. A total of 187 participants (mean age 60.1 ± 11.3years; 47% women; mean baseline 25(OH)D 21.1 ± 5.6 ng/mL) completed the trial. ANCOVA revealed a mean treatment effect for none of the respective outcomes and no significant results were detected in various subgroup analyses.

Conclusion: Vitamin D3 supplementation in hypertensive patients with insufficient 25(OH)D concentrations has no significant effect on lowering markers of systemic inflammation. Further studies investigating the effect of vitamin D on other inflammatory pathways and in populations with severe vitamin D deficiency and a significant inflammatory burden are required.

Registration: ClinicalTrials.gov Identifier: NCT02136771; EudraCT No. 2009-018,125-70. Start Date: 2011-04-06.

Keywords: Hypertension; Inflammation; Randomized controlled trial; Supplementation; Vitamin D.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Austria
  • Biomarkers / blood
  • Cholecalciferol / adverse effects
  • Cholecalciferol / therapeutic use*
  • Dietary Supplements* / adverse effects
  • Double-Blind Method
  • Female
  • Humans
  • Hypertension / blood
  • Hypertension / diagnosis
  • Hypertension / drug therapy*
  • Hypertension / immunology
  • Inflammation Mediators / blood*
  • Male
  • Middle Aged
  • Time Factors
  • Treatment Outcome
  • Vitamin D / analogs & derivatives*
  • Vitamin D / blood
  • Vitamin D Deficiency / blood
  • Vitamin D Deficiency / diagnosis
  • Vitamin D Deficiency / drug therapy*
  • Vitamins / adverse effects
  • Vitamins / therapeutic use*

Substances

  • Biomarkers
  • Inflammation Mediators
  • Vitamins
  • Vitamin D
  • Cholecalciferol
  • 25-hydroxyvitamin D

Associated data

  • ClinicalTrials.gov/NCT02136771
  • EudraCT/2009-018,125-70