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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275650
• Other study ID #: maintenance_uv
• Status: Completed
• Phase: N/A
• First received: October 19, 2014
• Last updated: October 23, 2014
• Start date: September 2013
• Est. completion date: May 2014

Study information

• Verified date: October 2014
• Source: Joint Authority for Päijät-Häme Social and Health Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Radiation:
• nbUVB
2 SED nbUVB exposure will be given every other week

Locations

Country	Name	City	State
Finland	Päijät-Häme Central Hospital	Lahti	Pirkanmaa
Finland	Tampere University Hospital	Tampere	Pirkanmaa

Sponsors (2)

Lead Sponsor	Collaborator
Joint Authority for Päijät-Häme Social and Health Care	Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25(OH)D level	Serum 25(OH)D levels were measured at the onset and at weeks 6, 14, 20, 26 and 30.	up to 30 weeks	No
Secondary	CYP27A1 and CYP27B1 enzyme expression levels	CYP27A1 and CYP27B1 enzyme expression levels will be analysed from 6mm punch biopsies at the onset and at week 14.	up to 14 weeks	No