Vitamin D Improves Depression in Liver Patients

NCT ID: NCT02359266

Last Updated: 2015-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-12-31

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.

Conditions

Depression; Chronic Liver Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin D supplement

20,000 IU cholecalciferol p.o for the first 7 days, and weekly thereafter for 6 months

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Given to patients with existing vitamin D deficiency

Controls

These patients had normal vitamin D levels and did not receive any treatment with vitamin D.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vitamin D

Given to patients with existing vitamin D deficiency

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

cholecalciferol

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universität des Saarlandes

OTHER

Sponsor Role: lead

Responsible Party

Dr. Caroline Stokes

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Lammert, MD

Role: STUDY_CHAIR

Saarland University Medical Center

Caroline S Stokes, PhD

Role: PRINCIPAL_INVESTIGATOR

Saarland University Medical Center

Locations

Saarland University Medical Center

Homburg, Saarland, Germany

Countries

Germany

Other Identifiers

SaarlandU

Identifier Type: -

Identifier Source: org_study_id