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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
History of Changes
  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:

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

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
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

Additional relevant MeSH terms:
Vitamin D
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013