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

Not Applicable

• Conditions: F32; K70-K77; Diseases of liver; Depressive episode

• Registration Number: DRKS00007782
• Lead Sponsor: Saarland University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2013-12-19
• Study Start: 2015-02-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes to serum liver function tests (ALT, AST, AP, GGT, Bilirubin, Albumin) after 3 and 6 months, as assessed using standard clinical-chemical assays<br><br>changes to bone density after 12 months, assessed using Dexa scans