Trial document





This trial has been registered retrospectively.
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  DRKS00007782

Trial Description

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Title

Clinical trial investigating the role of vitamin D in the treatment of depression in patients with chronic liver disease

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Trial Acronym

CLDVitD Trial

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study assesses whether depressive symptoms improve after vitamin D replacement therapy in patients with chronic liver disease and vitamin D deficiency. We gave vitamin D supplements to patients with chronic liver disease and vitamin D deficiency. Those with no vitamin D deficiency received no supplements. We hypothesise that depressive symptoms will improve once vitamin D levels increase following supplementation with vitamin D.

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Brief Summary in Scientific Language

Patients with chronic liver diseases regularly suffer from vitamin D deficiency and depression. A recent meta-analysis reported an inverse correlation between depression and vitamin D levels. Indeed, vitamin D receptor is present and genomic and nongenomic vitamin D receptor-mediated signalling has been described in brain. This intervention study investigates whether vitamin D therapy ameliorates depressive symptoms in chronic liver disease patients.We hypothesise that depressive symptoms will improve upon vitamin D replacement therapy.

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Organizational Data

  •   DRKS00007782
  •   2015/02/05
  •   [---]*
  •   yes
  •   Approved
  •   57/11, Ethik-Kommission bei der Ärztekammer des Saarlandes
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Secondary IDs

  •   U1111-1166-9516 
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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   K70-K77 -  Diseases of liver
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Interventions/Observational Groups

  •   Vitamin D supplements (20,000 IU Dekristol p.o. daily for 7 days, thereafter weekly) for 6 months

    Patients: with chronic liver disease and vitamin D deficiency with or without depression. We created subgroups based on presence of depressive symptoms.
  •   Patients with normal vitamin D levels were followd up during the same time periods, but were not given any vitamin D supplelments.

    Patients: with chronic liver disease with or without depression, but not vitamin D deficiency.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Changes to depressive symptoms after 3 and 6 months of vitamin D supplementation, as assessed using the BDI-II instrument

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Secondary Outcome

Changes to serum liver function tests (ALT, AST, AP, GGT, Bilirubin, Albumin) after 3 and 6 months, as assessed using standard clinical-chemical assays

changes to bone density after 12 months, assessed using Dexa scans

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/12/15
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- men and women
- over 18 years of age
- chronic liver disease

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Exclusion Criteria

- severe hepatic encephalopathy (CFF <35 Hz)
- Interferon treatment
- hypercalcaemia (>2.7 mmol/l) or hypercalciuria (>8.0 mmol/d) with or without hyperparathyroidism (>65.0 pg/ml)
- history of calcium-containing kidney stones
- allergy or hypersensitivity to any of the supplement ingredients: peanuts, soy, gelatin
- sarcoidosis
- stage IV or V Chronic Kidney Disease
- Pregnancy

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Addresses

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    • Saarland University Medical Center
    • 66421  Homburg
    • Germany
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    • Saarland University Medical Center
    • Mr.  Prof.  Frank  Lammert 
    • Department of Internal Medicine II, Kirrberger Str. 1
    • 66421  Homburg
    • Germany
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    • Saarland University Medical Center
    • Mr.  Prof.  Frank  Lammert 
    • Department of Internal Medicine II, Kirrberger Str. 1
    • 66421  Homburg
    • Germany
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Sources of Monetary or Material Support

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    • Saarland University Medical Center
    • Mr.  Prof.  Frank  Lammert 
    • Department of Internal Medicine II, Kirrberger Str. 100
    • 66421  Homburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/12/19
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Trial Publications, Results and other Documents

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