Vitamin D Improves Depression in Liver Patients (CLDVitD)

February 6, 2015 updated by: Dr. Caroline Stokes, Universität des Saarlandes

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Saarland University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D supplement
20,000 IU cholecalciferol p.o for the first 7 days, and weekly thereafter for 6 months
Dietary supplement: Vitamin D
Given to patients with existing vitamin D deficiency
Other Names:
  • cholecalciferol
No Intervention: Controls
These patients had normal vitamin D levels and did not receive any treatment with vitamin D.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes to depressive symptoms as assessed using the BDI-II score
Time Frame: 3 and 6 months
3 and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universität des Saarlandes

Investigators

  • Study Chair: Frank Lammert, MD, Saarland University Medical Center
  • Principal Investigator: Caroline S Stokes, PhD, Saarland University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 4, 2015

First Submitted That Met QC Criteria

February 6, 2015

First Posted (Estimate)

February 9, 2015

Study Record Updates

Last Update Posted (Estimate)

February 9, 2015

Last Update Submitted That Met QC Criteria

February 6, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SaarlandU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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