NCT02334592

Brief Summary

Health Canada's Radiation Emitting Devices (RED) Act provides exposure time guidelines for sunbed use. These guidelines are intended to protect sunbed users from overexposure to UV radiation. Overexposure is defined as "exposure that exceeds the amount needed for vitamin D production and could lead to skin or eye damage. Acute overexposure induces sunburn." However, the effect of the recommended time exposure schedule on serum 25(OH)D response has not been characterized. Further, it is unknown if the maximum time exposures are required to reach and/or maintain optimal 25(OH)D levels. The aim of the current study is to characterize serum 25(OH)D response to regular sunbed use following the time exposure schedule recommended by Health Canada.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable healthy

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4 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
8 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2015

Completed
Last Updated

January 8, 2015

Status Verified

December 1, 2013

Enrollment Period

4 months

First QC Date

January 6, 2015

Last Update Submit

January 7, 2015

Conditions

Keywords

the effect of tanningvitamin D production

Outcome Measures

Primary Outcomes (1)

  • To characterize serum 25(OH)D response to regular sunbed use, when performed according to the RED Act exposure time guidelines

    12 weeks

Secondary Outcomes (2)

  • To characterize serum 25(OH)D response with respect to sunbed lamp output (100W, 160W and High Pressure).

    12 weeks

  • To characterize serum 25(OH)D level with respect to skin lightness.

    12 weeks

Study Arms (4)

Low Pressure 100W sunbed

EXPERIMENTAL
Radiation: Sunbed tanning

Low Pressure 160W sunbed

EXPERIMENTAL
Radiation: Sunbed tanning

High Pressure sunbed

EXPERIMENTAL
Radiation: Sunbed tanning

Control group

NO INTERVENTION

Interventions

Invention groups undergo a 12-week tanning protocol that follows Health Canada's RED Act

High Pressure sunbedLow Pressure 100W sunbedLow Pressure 160W sunbed

Eligibility Criteria

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

You may qualify if:

  • years and older, male or female

You may not qualify if:

  • History of skin cancer, granulomatous disease, liver disease, or kidney disease
  • Photosensitive medications
  • Pregnancy
  • Vitamin D supplementation within last 60 days
  • Sunbed use within last 60 days
  • Planned travel to sunny destination during study period (January to April 2014)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kimball SM, Lee J, Vieth R. Sunbeds with UVB radiation can produce physiological levels of serum 25-Hydroxyvitamin D in healthy volunteers. Dermatoendocrinol. 2017 Oct 17;9(1):e1375635. doi: 10.1080/19381980.2017.1375635. eCollection 2017.

Study Design

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

Study Record Dates

First Submitted

January 6, 2015

First Posted

January 8, 2015

Study Start

January 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

January 8, 2015

Record last verified: 2013-12