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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02505282
Acronym
VITKOH
Enrollment
49
Registered
2015-07-22
Start date
2012-04-30
Completion date
2014-08-31
Last updated
2015-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthostatic Hypotension

Keywords

Orthostatic hypotension, Vitamin K

Brief summary

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.

Interventions

OTHERVitamin K status

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

Sponsors

British Geriatrics Society
CollaboratorOTHER
University of Dundee
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Serum non-phosphorylated, non-carboxylated Matrix Gla ProteinDay 1

Secondary

MeasureTime frameDescription
Vitamin DDay 1
Flow mediated dilatationDay 1Measure of endothelial function
Vitamin K1 LevelDay 1
Carotid intima media thicknessDay 1
Pulse wave augmentation indexDay 1Measure of arterial stiffness and refelctivity
Pulse wave velocityDay 1Measure of arterial stiffness and reflectivity

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026