NCT02275650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
Last Updated

October 27, 2014

Status Verified

October 1, 2014

Enrollment Period

8 months

First QC Date

October 19, 2014

Last Update Submit

October 23, 2014

Conditions

Vitamin D Deficiency

Keywords

calcidiol25(oh)dnbUVBcyp27A1cyp27B1vitamin D

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • CYP27A1 and CYP27B1 enzyme expression levels

    up to 14 weeks

Study Arms (2)

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

nbUVBRADIATION

2 SED nbUVB exposure will be given every other week

nbUVB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age over 18
  • Fitzpacker's skin type II-IV

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Päijät-Häme Central Hospital

Lahdenkylä, Pirkanmaa, 15850, Finland

Location

Tampere University Hospital

Tampere, Pirkanmaa, 33521, Finland

Location

MeSH Terms

Conditions

Vitamin D DeficiencyXanthomatosis, Cerebrotendinous

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLipid Metabolism DisordersMetabolic DiseasesXanthomatosis

Study Officials

  • Toni T Karppinen, MD

    Päijät Häme Central Hospital

    PRINCIPAL INVESTIGATOR

  • Erna Snellman, professor

    Tampere University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2014

First Posted

October 27, 2014

Study Start

September 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

October 27, 2014

Record last verified: 2014-10

Locations

FI(2)