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Trial record 70 of 123 for:    hypertension "vitamin d"

A Trial of Daily Ultraviolet Therapy to Reduce Cardiovascular Risk Factors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02621866
Recruitment Status : Unknown
Verified July 2017 by University of Edinburgh.
Recruitment status was:  Recruiting
First Posted : December 4, 2015
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh

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.


Condition or disease Intervention/treatment Phase
Hypertension Device: Ultraviolet A radiation Device: Sham irradiation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Trial of Daily Ultraviolet Therapy to Reduce Cardiovascular Risk Factors
Actual Study Start Date : May 2, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active
UVA irradiation.
Device: 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)
Other Name: UVA

Sham Comparator: Sham UVA irradiation 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.
Other Name: Screened UVA lamp




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: Two weeks ]
    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.

  2. Heart rate [ Time Frame: Two weeks ]
    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.

  3. Body Mass Index [ Time Frame: Two weeks ]
    Change in body mass index measured in clinical research facility before and after active and sham intervention period

  4. Waist-Hip Ratio [ Time Frame: Two weeks ]
    Change in waist-hip ratio. Measured in clinical research facility before and after active or sham intervention period

  5. Lipid profile [ Time Frame: Two weeks ]
    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.

  6. Adipokine profile [ Time Frame: Two weeks ]
    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.

  7. Glucose tolerance test [ Time Frame: Two weeks ]

    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


  8. HbA1c (glycosylated haemoglobin) [ Time Frame: Two weeks ]
    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.

  9. Fasting insulin level [ Time Frame: Two weeks ]
    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.

  10. Bio-impedance for body fat [ Time Frame: Two weeks ]
    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.

  11. Serum Vitamin D level [ Time Frame: Two weeks ]
    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.

  12. Adaptive pigmentation [ Time Frame: Two weeks ]
    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.

  13. Mood [ Time Frame: Two weeks ]
    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.

  14. Physical activity level- composite measure. [ Time Frame: Two weeks ]
    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.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02621866


Contacts
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Contact: Richard B Weller, MD, FRCP +44 (0) 1315362041 r.weller@ed.ac.uk
Contact: David J Webb, MD FRCP FRSE +44 (0)131 242 9216 David.J.Webb@ed.ac.uk

Locations
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United Kingdom
Clinical Research Centre and Pharmacology Unit, Western General Hospital Recruiting
Edinburgh, United Kingdom, EH4 2XU
Contact: Vanessa Melville, RGN    0131 537 2008      
Contact: Richard Weller, MD    01315362041      
Sponsors and Collaborators
University of Edinburgh
Investigators
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Principal Investigator: Richard B Weller, MD FRCP University of Edinburgh

Publications of Results:
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02621866     History of Changes
Other Study ID Numbers: PG/15/23/31362
First Posted: December 4, 2015    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Edinburgh:
hypertension
ultraviolet

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases