HypertensionNCT02621866
A Trial of Daily Ultraviolet Therapy to Reduce Cardiovascular Risk Factors
A study testing Ultraviolet A radiation in people with Hypertension, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
The investigators have shown that a single dose of ultraviolet irradiation (as found in sunlight) will lower blood pressure for around one hour. They are now testing whether daily UVA for two weeks will produce a sustained fall in BP in patients with high blood pressure. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Ultraviolet A radiation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 May 2017to 31 Aug 2019
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pre-hypertensives (BP 120-139/80-89).
- Fitzpatrick skin types 2 and above (i.e. the ability to tan)
Who cannot join
- History of skin cancer.
- Fitzpatrick type 1 skin (always burns, never tans).
- Red hair.
- Family history of melanoma in first degree relative.
- Atypical naevus syndrome.
- Planned holiday or foreign travel during and for 4 weeks before the period of the study.
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- Concurrent administration of:
- anti-hypertensive medication,
- photosensitising medication,
- systemic immunosuppressive medication.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Research Centre and Pharmacology Unit, Western General Hospital
Edinburgh, EH4 2XU
About this study
The investigators have shown that a single dose of ultraviolet irradiation (as found in sunlight) will lower blood pressure for around one hour. They are now testing whether daily UVA for two weeks will produce a sustained fall in BP in patients with high blood pressure.
They will also measure the effect of daily UVA on other cardiovascular risk factors.
Read the detailed description
Epidemiological studies suggest that sunlight reduces all cause mortality, and particularly cardiovascular mortality.
The investigators have previously shown vasodilatation and a transient fall in blood pressure following irradiation of human volunteers with 2 standard erythemal doses of UVA radiation. This was independent of vitamin D and temperature rise and correlated with a nitric oxide synthase independent mobilisation of NO stores from the skin to the systemic circulation.
In this randomised, sham-controlled, cross-over double blind study, they will measure whether twice daily UVA administration can produce a sustained fall in BP and other cardiovascular risk factors in a cohort of pre-hypertensive patients.
- Conditions
- Hypertension
- Being tested
- Ultraviolet A radiation, Sham irradiation
- Keywords
- hypertension, ultraviolet
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultraviolet A radiationDevice
Also called UVA
Twice daily with 10 Joules/cm2. Half body (one side) with Waldmann 100L phototherapy lamp fitted with UVA bulbs (main emission 320-410nm)
Sham irradiationDevice
Also called Screened UVA lamp
As active, but lamps to be shielded with Amber 81 museum film which prevents transmission of <500nm, but permits visible light to pass.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | UVA irradiation. Receives: Device: Ultraviolet A radiation |
| Sham UVA irradiation | Sham comparator | Not described Receives: Device: Sham irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour ambulatory blood pressure measurement
Before and after active and sham intervention period. Subjects will wear a 24 hour ambulatory blood pressure monitor for the 24 hour period before and after each 2 week intervention period. Change in 24 hour ambulatory blood pressure measurement will be the outcome measure.
Measured: Two weeks
Secondary outcomes (14)
Blood pressure
Measured with a mercury sphygmomanometer in clinical research facility. Change in blood pressure between the before and after measurements in the active and sham intervention.
Measured: Two weeks
Heart rate
Change in heart rate between the before and after measurements of the active and sham intervention. This will be measured manually in clinical research facility before and after active or sham intervention period.
Measured: Two weeks
Body Mass Index
Change in body mass index measured in clinical research facility before and after active and sham intervention period
Measured: Two weeks
Waist-Hip Ratio
Change in waist-hip ratio. Measured in clinical research facility before and after active or sham intervention period
Measured: Two weeks
Lipid profile
Change in lipid profile. Blood will be taken in the clinical research facility before and after active and sham intervention period. Analysis will be performed by the core specialist assay service at the adjacent Queens Medical Research Institute of the University of Edinburgh. Lipids are measured as a continuous variable.
Measured: Two weeks
Adipokine profile
Change in adipokine profile. Blood will be taken in the clinical research facility before and after active and sham intervention period. Analysis will be performed by the core specialist assay service at the adjacent Queens Medical Research Institute of the University of Edinburgh. Adipokines are measured as a continuous variable.
Measured: Two weeks
Glucose tolerance test
The standard National Health Service Lothian Glucose Tolerance Test protocol will be carried out and changes in outcome measures recorded. These will be the fasting glucose and the two hour glucose level. Both are continuous variables.
Phlebotomy and glucose administration wil be performed in the clinical research facility before and after active and sham intervention period
Measured: Two weeks
HbA1c (glycosylated haemoglobin)
Change in glycosylated haemoglobin level. Blood will be taken in the clinical research facility before and after active and sham intervention period. Analysis will be performed by the core specialist assay service at the adjacent Queens Medical Research Institute of the University of Edinburgh. Glycosylated haemoglobin is measured as a continuous variable.
Measured: Two weeks
Fasting insulin level
Change in fasting insulin level. Fasting blood will be taken in the clinical research facility before and after active and sham intervention period. Analysis will be performed by the core specialist assay service at the adjacent Queens Medical Research Institute of the University of Edinburgh. Insulin levels are measured as a continuous variable.
Measured: Two weeks
Bio-impedance for body fat
Changes in body fat levels. These are measured in clinical research facility before and after active or sham intervention period. This is a continuous variable.
Measured: Two weeks
Serum Vitamin D level
Changes in serum Vitamin D level. This is a continuous variable. Blood will be taken in the clinical research facility before and after active or sham intervention period. Analysis will be performed by the core specialist assay service at the adjacent Queens Medical Research Institute of the University of Edinburgh.
Measured: Two weeks
Adaptive pigmentation
Changes in pigmentation. Measured in clinical research facility before and after active or sham intervention period. Colour will be measured on UV exposed back skin using a chromameter and the L*a*b*score. This is a continuous variable.
Measured: Two weeks
Mood
Changes in mood. Patients will complete a mood questionnaire in the clinical research facility at the appointment before and after the active or sham intervention period. This is a continuous variable.
Measured: Two weeks
Physical activity level- composite measure.
Differences in activity levels will be compared between active, sham and washout periods. A composite measure derived from the peak, mean, and overall activity will be recorded. Overall activity will be calculated as area under the curve over the measurement period. Activity will be measured as movement, recorded by continually worn actiwatches (movement monitors) throughout the duration of the study. These will be set to record movement in 1 minute epochs.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study start2 May 2017
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard B Weller, MD FRCP, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621866
- Sponsor's protocol ID
- PG/15/23/31362
- Status last verified
- Sep 2019
- First submitted
- 25 Jun 2015
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu D, Fernandez BO, Hamilton A, Lang NN, Gallagher JMC, Newby DE, Feelisch M, Weller RB. UVA irradiation of human skin vasodilates arterial vasculature and lowers blood pressure independently of nitric oxide synthase. J Invest Dermatol. 2014 Jul;134(7):1839-1846. doi: 10.1038/jid.2014.27. Epub 2014 Jan 20.
PubMed 24445737
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Daily Ultraviolet Therapy to Reduce Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT02621866
- Acronym / sponsor ID
- PG/15/23/31362
- Conditions
- Hypertension
- Keywords
- hypertension, ultraviolet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 4 Dec 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.
The investigators have shown that a single dose of ultraviolet irradiation (as found in sunlight) will lower blood pressure for around one hour. They are now testing whether daily UVA for two weeks will produce a sustained fall in BP in patients with high blood pressure.
They will also measure the effect of daily UVA on other cardiovascular risk factors.
Detailed description
Epidemiological studies suggest that sunlight reduces all cause mortality, and particularly cardiovascular mortality.
The investigators have previously shown vasodilatation and a transient fall in blood pressure following irradiation of human volunteers with 2 standard erythemal doses of UVA radiation. This was independent of vitamin D and temperature rise and correlated with a nitric oxide synthase independent mobilisation of NO stores from the skin to the systemic circulation.
In this randomised, sham-controlled, cross-over double blind study, they will measure whether twice daily UVA administration can produce a sustained fall in BP and other cardiovascular risk factors in a cohort of pre-hypertensive patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: Ultraviolet A radiationUVA irradiation. |
| Sham UVA irradiation | Sham comparator | Device: Sham irradiation |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pre-hypertensives (BP 120-139/80-89).
- Fitzpatrick skin types 2 and above (i.e. the ability to tan)
Key exclusion criteria (10 listed)
- History of skin cancer.
- Fitzpatrick type 1 skin (always burns, never tans).
- Red hair.
- Family history of melanoma in first degree relative.
- Atypical naevus syndrome.
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 |
|---|---|---|
| Ultraviolet A radiationAlso: UVATwice daily with 10 Joules/cm2. Half body (one side) with Waldmann 100L phototherapy lamp fitted with UVA bulbs (main emission 320-410nm) | Device | Active |
| Sham irradiationAlso: Screened UVA lampAs active, but lamps to be shielded with Amber 81 museum film which prevents transmission of <500nm, but permits visible light to pass. | Device | Sham UVA irradiation |
Primary outcome
24 hour ambulatory blood pressure measurement
Time frame: Two weeks
Before and after active and sham intervention period. Subjects will wear a 24 hour ambulatory blood pressure monitor for the 24 hour period before and after each 2 week intervention period. Change in 24 hour ambulatory blood pressure measurement will be the outcome measure.
14 secondary outcomes
Blood pressure
Time frame: Two weeks
Heart rate
Time frame: Two weeks
Body Mass Index
Time frame: Two weeks
Waist-Hip Ratio
Time frame: Two weeks
Lipid profile
Time frame: Two weeks
Adipokine profile
Time frame: Two weeks
Glucose tolerance test
Time frame: Two weeks
HbA1c (glycosylated haemoglobin)
Time frame: Two weeks
Fasting insulin level
Time frame: Two weeks
Bio-impedance for body fat
Time frame: Two weeks
Serum Vitamin D level
Time frame: Two weeks
Adaptive pigmentation
Time frame: Two weeks
Mood
Time frame: Two weeks
Physical activity level- composite measure.
Time frame: Two weeks
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Results publication: PubMed 24445737Liu D, Fernandez BO, Hamilton A, Lang NN, Gallagher JMC, Newby DE, Feelisch M, Weller RB. UVA irradiation of human skin vasodilates arterial vasculature and lowers blood pressure independently of nitric oxide synthase. J Invest Dermatol. 2014 Jul;134(7):1839-1846. doi: 10.1038/jid.2014.27. Epub 2014 Jan 20.
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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.
Richard B Weller, MD FRCP principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultraviolet A radiation in people with Hypertension, run by University of Edinburgh 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 2 inclusion and 10 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: stopped early, as of the sponsor's last update on 13 May 2024. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Poor recruitment). Results are not available in the source record.
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?
24 hour ambulatory blood pressure measurement (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02621866, which also lists 1 linked publication.
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 13 May 2024.