Orthostatic HypotensionVITKOHNCT02505282
Vitamin K Status and Markers of Vascular Function in Patients With and Without Postural Hypotension
An observational study of Orthostatic Hypotension, run by University of Dundee at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthostatic Hypotension
- What is being tested?
- Vitamin K status
- How many people
- 49 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Aged 65 years or older, not on warfarin, able to stand unaided, able to give informed consent.
Who may be able to join
- 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.
Who cannot join
- On warfarin
- Unable to consent
- Unable to stand unaided
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Orthostatic Hypotension
- Being tested
- Vitamin K status
- Keywords
- Orthostatic hypotension, Vitamin K
- Medical subject headings
- Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K statusOther
Vitamin K status indicated by desphospho-uncarboxylated matrix Gla protein level
| Study group | Role | What they receive |
|---|---|---|
| Orthostatic Hypotension | >20mmHg systolic BP drop or >10mmHg diastolic BP drop on standing, and syncopal symptoms on standing Receives: Other: Vitamin K status | |
| Control | No fall in BP or <20mmHg systolic BP drop and <10mmHg diastolic BP drop on standing, and no syncopal symptoms on standing Receives: Other: Vitamin K status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum non-phosphorylated, non-carboxylated Matrix Gla Protein
Measured: Day 1
Secondary outcomes (6)
Vitamin K1 Level
Measured: Day 1
Vitamin D
Measured: Day 1
Flow mediated dilatation
Measure of endothelial function
Measured: Day 1
Pulse wave velocity
Measure of arterial stiffness and reflectivity
Measured: Day 1
Carotid intima media thickness
Measured: Day 1
Pulse wave augmentation index
Measure of arterial stiffness and refelctivity
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startApr 2012
- Primary completionJan 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- British Geriatrics Society
- Responsible party
- Principal investigator, Matthew Lambert, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505282
- Sponsor's protocol ID
- 2011CV14
- Acronym
- VITKOH
- Status last verified
- Jul 2015
- First submitted
- 20 Jul 2015
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin K Status and Markers of Vascular Function in Patients With and Without Postural Hypotension
- ClinicalTrials.gov ID
- NCT02505282
- Acronym / sponsor ID
- VITKOH / 2011CV14
- Conditions
- Orthostatic Hypotension
- Keywords
- Orthostatic hypotension, Vitamin K
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- British Geriatrics Society
- Study start
- Apr 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthostatic Hypotension | – | Other: Vitamin K status>20mmHg systolic BP drop or >10mmHg diastolic BP drop on standing, and syncopal symptoms on standing |
| Control | – | Other: Vitamin K statusNo fall in BP or <20mmHg systolic BP drop and <10mmHg diastolic BP drop on standing, and no syncopal symptoms on standing |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Aged 65 years or older, not on warfarin, able to stand unaided, able to give informed consent.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- On warfarin
- Unable to consent
- Unable to stand unaided
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin K statusVitamin K status indicated by desphospho-uncarboxylated matrix Gla protein level | Other | Control, Orthostatic Hypotension |
Primary outcome
Serum non-phosphorylated, non-carboxylated Matrix Gla Protein
Time frame: Day 1
6 secondary outcomes
Vitamin K1 Level
Time frame: Day 1
Vitamin D
Time frame: Day 1
Flow mediated dilatation
Time frame: Day 1
Pulse wave velocity
Time frame: Day 1
Carotid intima media thickness
Time frame: Day 1
Pulse wave augmentation index
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthostatic Hypotension, run by University of Dundee at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum non-phosphorylated, non-carboxylated Matrix Gla Protein (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2015.