Skip to main content
OpenTrials
Completed

NCT Number: NCT02505282

Vitamin K Status and Markers of Vascular Function in Patients With and Without Postural Hypotension

Postural hypotension is common in older people, leading to falls, decline in function, and dependence. Available treatments have limited efficacy and tolerability; novel approaches to treatment are therefore needed. Decreased vascular health, stiffening of the arteries and consequent decreased vascular reactivity are thought to contribute to postural hypotension and are therefore therapeutic targets.

Recent trial evidence has suggested that vitamin K may exert beneficial effects on vascular health particularly in respect to inhibiting calcification. Calcification increases vascular stiffness, decreases compliance and thus decreases the ability of blood vessels to autoregulate blood pressure and flow - which could contribute to postural drops in blood pressure. Worsened vascular health could also impact adversely on baroceptor function, which is needed for blood pressure autoregulation and which is disrupted in patients with orthostatic hypotension.

Vitamin K intake is below recommended daily intake in 60% of adults in the UK. In animals, vitamin K supplementation may be able to reverse calcification of arteries, and in humans Vitamin K has been shown to arrest decline in carotid artery elasticity compared to placebo. High levels of circulating vitamin K were also associated with lower levels of CRP in the Framingham cohort, suggesting a possible role in the suppression of chronic inflammation that is known to accompany vascular disease. The recent ECKO study suggested that vitamin K may reduce falls and fractures; an intriguing question that follows on from this is whether this could be due to beneficial effects on vascular health and postural hypotension, leading to less dizziness and reduced falls.

This cross-sectional comparative study aims to find whether there is a difference in the vitamin K status of patients with postural hypotension compared to those without postural hypotension and whether differences in vitamin K status are associated with other markers of vascular function in patients with and without postural hypotension. This could potentially lead to new treatments for the condition for which there is currently little of proven benefit.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Univeristy of Dundee

Dundee, Angus, DD1 9SY, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 65 years or older
  • For postural hypotension group: >20mmHg systolic BP drop or >10mmHg diastolic BP drop on standing, and syncopal symptoms on standing.
  • For control group: no fall in BP or <20mmHg systolic BP drop and <10mmHg diastolic BP drop on standing, and no syncopal symptoms on standing. No previous diagnosis of orthostatic hypotension.

Exclusion criteria

  • On warfarin
  • Unable to consent
  • Unable to stand unaided

Treatment and study plan

Vitamin K status

Other

Vitamin K status indicated by desphospho-uncarboxylated matrix Gla protein level

Primary outcomes

  1. Serum non-phosphorylated, non-carboxylated Matrix Gla Protein

    Time frame: Day 1

Secondary outcomes

  1. Vitamin K1 Level

    Time frame: Day 1

  2. Vitamin D

    Time frame: Day 1

  3. Flow mediated dilatation

    Time frame: Day 1

    Measure of endothelial function

  4. Pulse wave velocity

    Time frame: Day 1

    Measure of arterial stiffness and reflectivity

  5. Carotid intima media thickness

    Time frame: Day 1

  6. Pulse wave augmentation index

    Time frame: Day 1

    Measure of arterial stiffness and refelctivity

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Collaborators

  • British Geriatrics Society

Registry information

Acronym: VITKOH

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 22, 2015
Registry last updated
Jul 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.