A Trial of Daily Ultraviolet Therapy to Reduce Cardiovascular Risk Factors

NCT ID: NCT02621866

Last Updated: 2024-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-02

Study Completion Date

2019-08-31

Brief Summary

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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

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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

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active

UVA irradiation.

Group Type EXPERIMENTAL

Ultraviolet A radiation

Intervention Type DEVICE

Twice daily with 10 Joules/cm2. Half body (one side) with Waldmann 100L phototherapy lamp fitted with UVA bulbs (main emission 320-410nm)

Sham UVA irradiation

Group Type SHAM_COMPARATOR

Sham irradiation

Intervention Type DEVICE

As active, but lamps to be shielded with Amber 81 museum film which prevents transmission of \<500nm, but permits visible light to pass.

Interventions

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Ultraviolet A radiation

Twice daily with 10 Joules/cm2. Half body (one side) with Waldmann 100L phototherapy lamp fitted with UVA bulbs (main emission 320-410nm)

Intervention Type DEVICE

Sham irradiation

As active, but lamps to be shielded with Amber 81 museum film which prevents transmission of \<500nm, but permits visible light to pass.

Intervention Type DEVICE

Other Intervention Names

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UVA Screened UVA lamp

Eligibility Criteria

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Inclusion Criteria

* Pre-hypertensives (BP 120-139/80-89).
* Fitzpatrick skin types 2 and above (i.e. the ability to tan)

Exclusion Criteria

* 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.
* Concurrent administration of:

* anti-hypertensive medication,
* photosensitising medication,
* systemic immunosuppressive medication.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard B Weller, MD FRCP

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

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Clinical Research Centre and Pharmacology Unit, Western General Hospital

Edinburgh, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 24445737 (View on PubMed)

Other Identifiers

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PG/15/23/31362

Identifier Type: -

Identifier Source: org_study_id

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