A Trial of Daily Ultraviolet Therapy to Reduce Cardiovascular Risk Factors

NCT02621866 | Terminated

• 1 other identifier: PG/15/23/31362
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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. They will also measure the effect of daily UVA on other cardiovascular risk factors.

Conditions

Hypertension

Keywords

hypertension; ultraviolet

Outcome Measures

Primary Outcomes (1)

• 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.

  Two weeks

Secondary Outcomes (14)

• Blood pressure

  Two weeks

• Heart rate

  Two weeks

• Body Mass Index

  Two weeks

• Waist-Hip Ratio

  Two weeks

• Lipid profile

  Two weeks

Study Arms (2)

Active

EXPERIMENTAL

UVA irradiation.

Device: Ultraviolet A radiation

Sham UVA irradiation

SHAM COMPARATOR

Device: Sham irradiation

Interventions

Ultraviolet A radiation DEVICE

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

Also known as: UVA

Active

Sham irradiation DEVICE

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

Also known as: Screened UVA lamp

Sham UVA irradiation

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

Clinical Research Centre and Pharmacology Unit, Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24445737 RESULT

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Richard B Weller, MD FRCP

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: December 4, 2015
• Study Start: May 2, 2017
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: May 13, 2024

Record last verified: 2019-09

Locations

GB (1)