Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00009001

Trial Description

start of 1:1-Block title

Title

Synthesis of vitamin-D3 in the skin after UV-radiation under various conditions (spectrum, intensity of radiation, dose, skin area) with regard to radiation protection requirements and sunblock application.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

In this study it shall be shown that short-term UV radiation enhances the vitamin D production in the skin in obese patients compared to Normal weight patients. The aim of this study is to show a good therapeutic effect on vitamin D production in obese and therefore to enable for an alternative treatment option in patients who do not benefit from oral intake. We test whether a low UV dose in obese is sufficient for a good therapeutic effect (increase of serum vitamin D).

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

This study investigates the influence of short-term ultraviolet B (UVB) irradiation on serum 25-hydroxyvitamin-D3 (25D) and 1,25-hydroxyvitamin-D3 (1,25D) levels in obese patients.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00009001
  •   2016/01/07
  •   [---]*
  •   yes
  •   Approved
  •   EA1/026/09, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   vitamin D deficiency in obese
  •   E55 -  Vitamin D deficiency
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   UV radiation in 12 obese patients with Waldmann GH-8 ST with a cumulated dose of 70J/m2 (0.28MED). Within one week three sessions were performed (Monday, Wednesday, Friday), radiation time varied between 43 and 85 seconds.
  •   UV radiation in 20 obese patients with Waldmann GH-8 ST with a cumulated dose of 175J/m2 (0.7MED). Within one week three sessions were performed (Monday, Wednesday, Friday), radiation time varied between 108 and 214 seconds.
  •   UV radiation in 20 obese patients with Waldmann GH-8 ST with a cumulated dose of 475.5J/m2 (1.75MED). Within one week three sessions were performed (Monday, Wednesday, Friday), radiation time varied between 285 and 537 seconds.
  •   20 obese patients were observed in an equal setting but did not recieve UV radiation (obese control group).
  •   UV radiation in 20normal weight patients with Waldmann GH-8 ST with a cumulated dose of 175J/m2 (0.7MED). Within one week three sessions were performed (Monday, Wednesday, Friday), radiation time varied between 108 and 214 seconds.
  •   20 normal weight patients were observed in an equal setting but did not recieve UV radiation (normal weight control group).
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment, Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Increase in 25-OH-vitamin D3 serum level between baseline (day 1) and follow-up (day 8).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Increase in 1,25-OH-vitamin D3 serum level between baseline (day 1) and follow-up (day 8).

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/01/02
  •   120
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

skin type II, III

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

skin diseases, renal failure, autoimmune diseases, previous stay in country with high sunlight radiation, oral vitamin D intake, or solarium visits within the last six months

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Charité - Universitätsmedizin Berlin
    • Mr.  Prof. Dr.  Ralf  Uebelhack 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Charité Campus Charité Mitte
    • Mr.  Dr.  Alexander   Obbarius 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2013/07/29
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.