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

Primary Purpose

Vitamin D Deficiency

Status

Completed

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

nbUVB

About this trial

This is an interventional prevention trial for Vitamin D Deficiency focused on measuring calcidiol, 25(oh)d, nbUVB, cyp27A1, cyp27B1, vitamin D

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Päijät-Häme Central Hospital
Tampere University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

nbUVB

control

Arm Description

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

No nbUVB illumination will be given for the control group.

Outcomes

Primary Outcome Measures

25(OH)D level

Serum 25(OH)D levels were measured at the onset and at weeks 6, 14, 20, 26 and 30.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02275650

First Posted

October 19, 2014

Last Updated

October 23, 2014

Sponsor

Joint Authority for Päijät-Häme Social and Health Care

Collaborators

Tampere University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02275650

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Joint Authority for Päijät-Häme Social and Health Care

Collaborators

Tampere University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency

Keywords

calcidiol, 25(oh)d, nbUVB, cyp27A1, cyp27B1, vitamin D

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

nbUVB

Arm Type

Experimental

Arm Description

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

Arm Title

control

Arm Type

No Intervention

Arm Description

No nbUVB illumination will be given for the control group.

Intervention Type

Radiation

Intervention Name(s)

nbUVB

Intervention Description

2 SED nbUVB exposure will be given every other week

Primary Outcome Measure Information:

Title

25(OH)D level

Description

Serum 25(OH)D levels were measured at the onset and at weeks 6, 14, 20, 26 and 30.

Time Frame

up to 30 weeks

Secondary Outcome Measure Information:

Title

CYP27A1 and CYP27B1 enzyme expression levels

Description

CYP27A1 and CYP27B1 enzyme expression levels will be analysed from 6mm punch biopsies at the onset and at week 14.

Time Frame

up to 14 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Toni T Karppinen, MD

Organizational Affiliation

Päijät Häme Central Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Erna Snellman, professor

Organizational Affiliation

Tampere University Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Päijät-Häme Central Hospital

City

Lahti

State/Province

Pirkanmaa

ZIP/Postal Code

15850

Country

Finland

Facility Name

Tampere University Hospital

City

Tampere

State/Province

Pirkanmaa

ZIP/Postal Code

33521

Country

Finland

12. IPD Sharing Statement

Learn more about this trial

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

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