Clinical trial NCT02621866: A Trial of Daily Ultraviolet Therapy to Reduce Cardiovascular Risk Factors
Official title: A Trial of Daily Ultraviolet Therapy to Reduce Cardiovascular Risk Factors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Keywords: hypertension
ultraviolet
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2015-12-04
Enrollment: 13
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 24 hour ambulatory blood pressure measurement
timeFrame: Two weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: Two weeks
measure: Heart rate
timeFrame: Two weeks
measure: Body Mass Index
timeFrame: Two weeks
measure: Waist-Hip Ratio
timeFrame: Two weeks
measure: Lipid profile
timeFrame: Two weeks
measure: Adipokine profile
timeFrame: Two weeks
measure: Glucose tolerance test
timeFrame: Two weeks
measure: HbA1c (glycosylated haemoglobin)
timeFrame: Two weeks
measure: Fasting insulin level
timeFrame: Two weeks
measure: Bio-impedance for body fat
timeFrame: Two weeks
measure: Serum Vitamin D level
timeFrame: Two weeks
measure: Adaptive pigmentation
timeFrame: Two weeks
measure: Mood
timeFrame: Two weeks
measure: Physical activity level- composite measure.
timeFrame: Two weeks
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Clinical Research Centre and Pharmacology Unit, Western General Hospital
Study officials:
affiliation: University of Edinburgh
name: Richard B Weller, MD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.