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The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter

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ClinicalTrials.gov Identifier: NCT02275650
Recruitment Status : Completed
First Posted : October 27, 2014
Last Update Posted : October 27, 2014
Sponsor:
Collaborator:
Tampere University Hospital
Information provided by (Responsible Party):
Joint Authority for Päijät-Häme Social and Health Care

Brief Summary:
The investigators investigated the ability of narrowband ultraviolet B (nbUVB) treatment in the maintenance of vitamin D levels achieved during the summer in Finland. The investigators randomized 37 subjects into groups of 17 and 18 subjects. The other group received 2 standard erythema doses (SED) nbUVB exposure every other week until week 24, and serum 25(OH)D levels were measured at the onset and at weeks 6, 14, 20, 26 and 30. The control group was not illuminated and serum samples were analyzed correspondingly. Punch biopsies were taken at the onset and at week 14 for CYP27A1 and CYP27B1 enzyme expression level analyses.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Radiation: nbUVB Not Applicable

Detailed Description:
The investigators investigated the ability of narrowband ultraviolet B (nbUVB) treatment in the maintenance of vitamin D levels achieved during the summer in Finland. The investigators randomized 37 subjects into groups of 17 and 18 subjects. The other group received 2 standard erythema doses (SED) nbUVB exposure every other week until week 24, and serum 25(OH)D levels were measured at the onset and at weeks 6, 14, 20, 26 and 30. The control group was not illuminated and serum samples were analyzed correspondingly. 6mm punch biopsies were taken at the onset and at week 14 for CYP27A1 and CYP27B1 enzyme expression level analyses.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter
Study Start Date : September 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: nbUVB
2 SED dose of nbUVB will be given every other week for this intervention group.
Radiation: nbUVB
2 SED nbUVB exposure will be given every other week

No Intervention: control
No nbUVB illumination will be given for the control group.



Primary Outcome Measures :
  1. 25(OH)D level [ Time Frame: up to 30 weeks ]
    Serum 25(OH)D levels were measured at the onset and at weeks 6, 14, 20, 26 and 30.


Secondary Outcome Measures :
  1. CYP27A1 and CYP27B1 enzyme expression levels [ Time Frame: up to 14 weeks ]
    CYP27A1 and CYP27B1 enzyme expression levels will be analysed from 6mm punch biopsies at the onset and at week 14.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age over 18
  • Fitzpacker's skin type II-IV

Exclusion Criteria:

  • age under 18
  • diseases that inhibit vitamin D metabolism or absorption
  • Fitzpacker's skin type I
  • history of skin cancer
  • vitamin D substitution 1 month before baseline or during study
  • sun holidays 1 month before baseline or during study

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): NCT02275650


Locations
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Finland
Päijät-Häme Central Hospital
Lahti, Pirkanmaa, Finland, 15850
Tampere University Hospital
Tampere, Pirkanmaa, Finland, 33521
Sponsors and Collaborators
Joint Authority for Päijät-Häme Social and Health Care
Tampere University Hospital
Investigators
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Principal Investigator: Toni T Karppinen, MD Päijänne Tavastia Central Hospital
Study Director: Erna Snellman, professor Tampere University Hospital
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Responsible Party: Joint Authority for Päijät-Häme Social and Health Care
ClinicalTrials.gov Identifier: NCT02275650    
Other Study ID Numbers: maintenance_uv
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: October 27, 2014
Last Verified: October 2014
Keywords provided by Joint Authority for Päijät-Häme Social and Health Care:
calcidiol
25(oh)d
nbUVB
cyp27A1
cyp27B1
vitamin D
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders