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

October 23, 2014 updated by: Joint Authority for Päijät-Häme Social and Health Care
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Pirkanmaa
      • Lahti, Pirkanmaa, Finland, 15850
        • Päijät-Häme Central Hospital
      • Tampere, Pirkanmaa, Finland, 33521
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 30 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joint Authority for Päijät-Häme Social and Health Care

Collaborators

Tampere University Hospital

Investigators

  • Principal Investigator: Toni T Karppinen, MD, Päijät-Häme Central Hospital
  • Study Director: Erna Snellman, professor, Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

October 19, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (Estimate)

October 27, 2014

Study Record Updates

Last Update Posted (Estimate)

October 27, 2014

Last Update Submitted That Met QC Criteria

October 23, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • maintenance_uv

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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