Production of Vitamin D Metabolites by UV-radiation From Solar Bed

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Louise Lind Schierbeck, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01261039
First received: December 15, 2010
Last updated: March 15, 2012
Last verified: March 2012

December 15, 2010
March 15, 2012
April 2010
February 2011   (final data collection date for primary outcome measure)
Vitamin D 25-OHD [ Time Frame: 8 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01261039 on ClinicalTrials.gov Archive Site
Changes in other calcium metabolic factors [ Time Frame: 8 days ] [ Designated as safety issue: No ]
Vitamin D3, Mg++, PTH, PO4--, Ca++
Same as current
Not Provided
Not Provided
 
Production of Vitamin D Metabolites by UV-radiation From Solar Bed
Production of Vitamin D Metabolites by UV-radiation From Solar Bed

Background:

Some patients do not readily absorb vitamin D from intestine. These patients may be helped by ultraviolet rays, which can come from sunlight or solar beds. When the skin is exposed to ultraviolet B rays (UVB) vitamin D is produced. This usually happens when the skin is exposed to sunlight. Vitamin D can also be ingested trough some foods, mainly fatty fish or supplements.

Vitamin D is important for bone, and long-term vitamin D deficiency can lead to osteoporosis. Vitamin D may also be important for the immune system—including autoimmune diseases—and the cardiovascular system.

Purpose:

The main purpose of the study is to learn more about the production of vitamin D3 in the skin, by ultraviolet radiation.

Study Course:

Day 0: Randomization. Subjects are randomized to two groups. Subjects in both groups will be exposed to light in a solar bed for approximately 10 minutes on the first day, but only one of the solar beds wields ultraviolet rays. The other has a filter, which filters out the ultraviolet rays.

Blood samples are drawn on the first day at following times: Before solar bed, after at 15 minutes, 1, 2, 4 and 6 hours.

Day 1,2,3 and 7 after solar bed exposure:

Blood samples are drawn and adverse events are registered.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Production of Vitamin D in Skin When Exposed to UV-B by Solar Bed.
Radiation: UV radiation
Subjects in both groups will be exposed to light in a solar bed for approximately 10 minutes (depending on Fitzpatrick skin type test) on the first day, but only one of the solar beds wields ultraviolet rays. The other has a filter, which filters out the ultraviolet rays.
  • Active Comparator: Solar bed UV-radiation
    Solar bed UV-radiation
    Intervention: Radiation: UV radiation
  • Sham Comparator: Solar bed with UV filter
    Solar bed with UV filter
    Intervention: Radiation: UV radiation
Langdahl JH, Schierbeck LL, Bang UC, Jensen JE. Changes in serum 25-hydroxyvitamin D and cholecalciferol after one whole-body exposure in a commercial tanning bed: a randomized study. Endocrine. 2012 Oct;42(2):430-5. Epub 2012 Mar 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

Healthy adults

Exclusion Criteria:

Abnormal ALT or Creatinine Pregnancy

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01261039
h-3-2009-145
No
Louise Lind Schierbeck, Hvidovre University Hospital
Hvidovre University Hospital
Not Provided
Study Chair: Jens-Erik B Jensen, MD, PhD Hvidovre University Hospital
Study Chair: Louise L Schierbeck, MD Dept. of Endocrinology
Study Chair: Ulrich Bang, MD Hvidovre University Hospital
Principal Investigator: Jakob H Langdahl University of Copenhagen
Hvidovre University Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP