Trial document





This trial has been registered retrospectively.
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  DRKS00009274

Trial Description

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Title

Vitamin D and mood in healthy young women during wintertime after three suberythemal UV irradiations - the MUVY pilot study

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Trial Acronym

MUVY (Mood, UV, Vitamin D in Young women)

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The primary objective of our clinical pilot trial “MUVY” (Mood, UV, Vitamin D in Young women) is to test both the short-term and long-term effects of three UV exposures (dosage beneath sunburn threshold) on the VitD status and the affective state of young healthy women during winter since Vitamin D deficiency is a health problem also prevalent in young adults.

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Brief Summary in Scientific Language

The primary objective of our clinical pilot trial “MUVY” (Mood, UV, Vitamin D in Young women) is to test both the short-term and long-term effects of three suberythemal UV exposures on the 25-hydroxyvitamin D and 1.25-dihydoxyvitamin D status and the affective state (measured by Beck Depression Inventory und Profile of Mood States self-rating scale) of young healthy women during winter since Vitamin D deficiency is a health problem also prevalent in young adults.

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Organizational Data

  •   DRKS00009274
  •   2015/09/01
  •   [---]*
  •   yes
  •   Approved
  •   EA1/026/09 , Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E55.9 -  Vitamin D deficiency, unspecified
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Interventions/Observational Groups

  •   20 young women,
    three UV-exposures:
    day 1 (skin type I 80 J/m², skin type II 100 J/m²)
    day 3 (skin tye I 120 J/m², skin type II 150 J/m²)
    day 5 (sin type I 150 J/m², sin type II 187.5 J/m²)
    blood samples (day 1, 8, 36 and 50)
    biometric and mood questionnaires (day 1 and 8)
  •   24 young women, no intervention
    biometric and mood questionnaires (day 1 and 8)
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   No treatment
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

measuring 25-hydroxyvitamin d and 1,25-dihydroxyvitamin d at day 1, 8, 36 and 50,
UV-exposures at day 1, 3 and 5

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Secondary Outcome

measuring mood parameters (using Beck Depression Inventory (BDI) and Profille of mood states (POMS) self-rating questionnaires) at day 1 and 8,
UV-exposures at day 1, 3 and 5

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/12/05
  •   44
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   20   Years
  •   30   Years
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Additional Inclusion Criteria

female, age 20-30, healthy, reliable

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Exclusion Criteria

skin or psychiatric conditions, oral Vitamin D intake, recent vacations to sunny countries

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Addresses

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité-Universitätsmedizin Berlin, Department of Rheumatology and Clinical ImmunologyTeam Insider
    • Ms.  Maria  Biersack 
    • Chariteplatz 1
    • 10117  Berlin
    • Germany
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    • Charité-Universitätsmedizin Berlin, Department of Rheumatology and Clinical ImmunologyTeam Insider
    • Ms.  Maria  Biersack 
    • Chariteplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Campus Charité Mitte
    • 10117  Berlin
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2012/05/30
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.