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

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Radiation: nbUVB

• Registration Number: NCT02275650
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-09
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-10
• Study First Submitted: 2014-10-19
• Study First Submitted QC: 2014-10-23
• Last Update Submitted: 2014-10-23
• Study First Posted: 2014-10-27
• Last Update Posted: 2014-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
25(OH)D level	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

Name	Time	Method
CYP27A1 and CYP27B1 enzyme expression levels	up to 14 weeks	CYP27A1 and CYP27B1 enzyme expression levels will be analysed from 6mm punch biopsies at the onset and at week 14.

Trial Locations

Locations (2)

Tampere University Hospital; 🇫🇮 Tampere, Pirkanmaa, Finland

Päijät-Häme Central Hospital; 🇫🇮 Lahti, Pirkanmaa, Finland