Trial document





This trial has been registered retrospectively.
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  DRKS00013485

Trial Description

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Title

Influence of vitamin D administration on the intestinal bacterial composition in CD patients and healthy controls

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

7 CD patients and 10 healthy controls with vitamin D deficiency were enrolled in the study. Vitamin D substitution was performed. The intestinal microbial composition was analyzed.

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Brief Summary in Scientific Language

CD patients and healthy controls with vitamin D deficiency were substituted with vitamin D. The intestinal bacterial composition was analyzed before and after vitamin D substitution.

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Organizational Data

  •   DRKS00013485
  •   2017/12/04
  •   [---]*
  •   yes
  •   Approved
  •   A-2016-0109, Ethik-Kommission an der Medizinischen Fakultät der Universität Rostock
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Secondary IDs

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Health Condition or Problem studied

  •   Crohn's disease
  •   K50 -  Crohn disease [regional enteritis]
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Interventions/Observational Groups

  •   Crohn's disease:
    The intervention was carried out by means of decristol 20,000 IU, every two days up to a target level between 100 and 150 nmol/l. At higher values, vitamin D substitution was suspended. The duration of the substitution was 4 weeks.
  •   Healthy Controls:
    The intervention was carried out by means of decristol 20,000 IU, every two days up to a target level between 100 and 150 nmol/l. At higher values, vitamin D substitution was suspended.
    The duration of the substitution was 4 weeks.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

The effect of vitamin D substitution on the intestinal bacterial composition in patients and controls with vitamin D deficiency has been studied. The examination was performed before vitamin D substitution (week 0), after week 1, week 2, week 3 and week 4. The stool samples were analyzed via NGS (next generation sequencing).

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/11/15
  •   17
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Crohn's disease with vitamin D deficiency
Healthy controls with vitamin D deficiency

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Exclusion Criteria

patient does not want to participate in the study

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Addresses

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    • Universitätsklinikum Rostock
    • Mr.  Dr   Holger  Schäffler 
    • Schillingallee 35
    • 18057  Rostock
    • Germany
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    • Universitätsklinikum Rostock
    • Mr.  Dr.  Holger  Schäffler 
    • Schillingallee 35
    • 18057  Rostock
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Universitätsklinikum Rostock
    • Mr.  Dr.  Holger  Schäffler 
    • Schillingallee 35
    • 18057  Rostock
    • Germany
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Sources of Monetary or Material Support

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    • Damp Stiftung
    • Wall 55
    • 24103  Kiel
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/05/05
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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.