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
  Purpose

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.


Condition Intervention
Production of Vitamin D in Skin When Exposed to UV-B by Solar Bed.
Radiation: UV radiation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Production of Vitamin D Metabolites by UV-radiation From Solar Bed

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Vitamin D 25-OHD [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in other calcium metabolic factors [ Time Frame: 8 days ] [ Designated as safety issue: No ]
    Vitamin D3, Mg++, PTH, PO4--, Ca++


Enrollment: 20
Study Start Date: April 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Solar bed UV-radiation
Solar bed UV-radiation
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.
Sham Comparator: Solar bed with UV filter
Solar bed with UV filter
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy adults

Exclusion Criteria:

Abnormal ALT or Creatinine Pregnancy

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261039

Locations
Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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
  More Information

No publications provided by Hvidovre University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Louise Lind Schierbeck, MD, research fellow, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01261039     History of Changes
Other Study ID Numbers: h-3-2009-145
Study First Received: December 15, 2010
Last Updated: March 15, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

ClinicalTrials.gov processed this record on October 16, 2014