The Role of Narrowband Ultraviolet B Exposure in the Main... | NCT02275650

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

NCT02275650

Sponsor

Joint Authority for Päijät-Häme Social and Health Care

Status

Completed

Last Update Posted

Oct 27, 2014Estimated

Enrollment

37Actual

Phase

Not Applicable

Conditions

Vitamin D Deficiency

Interventions

nbUVB

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Oct 19, 2014

First Submission Date that Met QC Criteria

Oct 23, 2014

First Posted Date

Oct 27, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2014

Last Update Posted Date

Oct 27, 2014Estimated

Name	Class
Tampere University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
nbUVB	Experimental	2 SED dose of nbUVB will be given every other week for this intervention group.	Radiation: nbUVB
control	No Intervention	No nbUVB illumination will be given for the control group.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nbUVB	Radiation	2 SED nbUVB exposure will be given every other week	nbUVB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Toni T Karppinen, MD	Päijät Häme Central Hospital	Principal Investigator
Erna Snellman, professor	Tampere University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Päijät-Häme Central Hospital		Lahdenkylä	Pirkanmaa	15850	Finland
Tampere University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D014808	Vitamin D Deficiency
D019294	Xanthomatosis, Cerebrotendinous

Ancestor Terms

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided