- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02334592
Vitamin D Production Levels Achieved by Sunbed Tanning
January 7, 2015 updated by: Vitamin D Society
The Impact of Health Canada's Sunbed Exposure Time Guidelines on Serum 25(OH)D Concentrations
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
87
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years and older, male or female
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control group
|
|
EXPERIMENTAL: Low Pressure 100W sunbed
|
Invention groups undergo a 12-week tanning protocol that follows Health Canada's RED Act
|
EXPERIMENTAL: Low Pressure 160W sunbed
|
Invention groups undergo a 12-week tanning protocol that follows Health Canada's RED Act
|
EXPERIMENTAL: High Pressure sunbed
|
Invention groups undergo a 12-week tanning protocol that follows Health Canada's RED Act
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To characterize serum 25(OH)D response to regular sunbed use, when performed according to the RED Act exposure time guidelines
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To characterize serum 25(OH)D response with respect to sunbed lamp output (100W, 160W and High Pressure).
Time Frame: 12 weeks
|
12 weeks
|
To characterize serum 25(OH)D level with respect to skin lightness.
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (ACTUAL)
May 1, 2014
Study Completion (ACTUAL)
May 1, 2014
Study Registration Dates
First Submitted
January 6, 2015
First Submitted That Met QC Criteria
January 7, 2015
First Posted (ESTIMATE)
January 8, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
January 8, 2015
Last Update Submitted That Met QC Criteria
January 7, 2015
Last Verified
December 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- VDS-1234
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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