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The Relation Between Vitamin D Production and UVB Exposed Body Surface Area

B

Bispebjerg Hospital

Status

Completed

Conditions

Vitamin D Status

Treatments

Radiation: Broadband UVB

Study type

Interventional

Funder types

Other

Identifiers

NCT01042197
H-B-2007-100

Details and patient eligibility

About

The purpose of this study is to investigate the relation between vitamin D production after UVB and exposed body surface areas with different UVB doses.

Full description

Vitamin D deficiency is very common. Rachitis, osteoporosis, cancer, sclerosis as well as cardiovascular diseases are related to vitamin D deficiency. Elderly people, immigrants as well as patients with malabsorption diseases often have vitamin D deficiency. 90-95 % of the total vitamin D requirements are obtained from the ultraviolet (UV) radiation of the skin.In spite of the risk of skin-cancer, treatment with sunlight radiation is often recommended against vitamin D deficiency. This fact has raised a scientific debate, where concern has been expressed with regard to the risk of skin-cancer. This dilemma should also be examined as no human studies are available on the vitamin D production in the skin after UV-radiation showing the frequency and dose necessary for sufficient production of vitamin D. The lowest exposure frequency, the smallest body surface area and the lowest UV dose should therefore be established to be exposed in order to minimize the risk of skin-cancer by unnecessary UV-radiation. The purpose of the project is therefore to clarify which factors there are of importance for the production of vitamin D in the skin after UVB radiation.

Enrollment

92 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy individuals between 18 - 65 years of age.
  • Avoidance of sun bed exposure
  • Not Holidaying south of 45 degrees latitude 3 months before
  • Avoiding vitamin D supplementation during and two months before

Exclusion criteria

  • Illness as well as age above 65 years.
  • Skin diseases
  • Psychiatric diseases
  • Drug addiction
  • Intake of photosensitive medicine.
  • Intake of cholesterol-lowering medicine.
  • Pregnancy

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

92 participants in 9 patient groups

2
Active Comparator group
Description:
Body surface area: 12 %
Treatment:
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
1
Active Comparator group
Description:
Body surface area: 6 %
Treatment:
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
3
Active Comparator group
Description:
Body surface area: 24 %
Treatment:
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
4
Active Comparator group
Description:
Body surface area: 6 %
Treatment:
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
5
Active Comparator group
Description:
Body surface area: 12 %
Treatment:
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
6
Active Comparator group
Description:
Body surface area: 24 %
Treatment:
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
7
Active Comparator group
Description:
Body surface area: 6 %
Treatment:
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
8
Active Comparator group
Description:
Body surface area: 12 %
Treatment:
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
9
Active Comparator group
Description:
Body surface area: 24 %
Treatment:
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB
Radiation: Broadband UVB

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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