Vitamin D Improves Depression in Liver Patients

Not Applicable

Completed

• Conditions: Chronic Liver Disease; Depression
• Interventions: Dietary Supplement: Vitamin D

• Registration Number: NCT02359266
• Lead Sponsor: Universität des Saarlandes

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-02
• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-02-06
• Last Update Submitted: 2015-02-06
• Study First Posted: 2015-02-09
• Last Update Posted: 2015-02-09

Recruitment & Eligibility

• Status: COMPLETED
• 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: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D supplement	Vitamin D	20,000 IU cholecalciferol p.o for the first 7 days, and weekly thereafter for 6 months

Primary Outcome Measures

Name	Time	Method
Changes to depressive symptoms as assessed using the BDI-II score	3 and 6 months

Secondary Outcome Measures

Name	Time	Method
Changes to serum liver function tests, as assessed using standard clinical-chemical assays	3 and 6 months
Changes to bone density, as assessed using Dexa scans	at 12 months

Trial Locations

Locations (1)

Saarland University Medical Center; 🇩🇪 Homburg, Saarland, Germany