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

NCT ID: NCT02275650

Last Updated: 2014-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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nbUVB

2 SED dose of nbUVB will be given every other week for this intervention group.

Group Type EXPERIMENTAL

nbUVB

Intervention Type RADIATION

2 SED nbUVB exposure will be given every other week

control

No nbUVB illumination will be given for the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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nbUVB

2 SED nbUVB exposure will be given every other week

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role collaborator

Joint Authority for Päijät-Häme Social and Health Care

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Toni T Karppinen, MD

Role: PRINCIPAL_INVESTIGATOR

Päijät Häme Central Hospital

Erna Snellman, professor

Role: STUDY_DIRECTOR

Tampere University Hospital

Locations

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Päijät-Häme Central Hospital

Lahdenkylä, Pirkanmaa, Finland

Site Status

Tampere University Hospital

Tampere, Pirkanmaa, Finland

Site Status

Countries

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Finland

Other Identifiers

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maintenance_uv

Identifier Type: -

Identifier Source: org_study_id

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