Vitamin D Improves Depression in Liver Patients

Depression Clinical Trial

— CLDVitD  

Official title:

Clinical Trial Investigating the Role of Vitamin D in the Treatment of Depression in Patients With Chronic Liver Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359266
• Other study ID #: SaarlandU
• Status: Completed
• Phase: N/A
• First received: February 4, 2015
• Last updated: February 6, 2015
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: February 2015
• Source: Saarland University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

This study evaluates the efficacy of vitamin D replacement therapy in reducing depressive symptoms in patients with chronic liver disease and vitamin D deficiency. Patients with normal vitamin D levels will be monitored as controls, and they will not receive any intervention.

Description:

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.

The investigators hypothesise that depressive symptoms will improve upon vitamin D replacement therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Liver Disease
• Depression
• Depressive Disorder
• Liver Diseases

Intervention

Dietary Supplement:
• Vitamin D
Given to patients with existing vitamin D deficiency

Locations

Country	Name	City	State
Germany	Saarland University Medical Center	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
Saarland University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes to depressive symptoms as assessed using the BDI-II score		3 and 6 months	Yes
Secondary	Changes to serum liver function tests, as assessed using standard clinical-chemical assays		3 and 6 months	No
Secondary	Changes to bone density, as assessed using Dexa scans		at 12 months	No