Back to resultsVitamin D Improves Depression in Liver Patients (CLDVitD)
Primary Purpose
Depression, Chronic Liver Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Mood, Vitamin D deficiency, Adjuvant treatment
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
Sites / Locations
- Saarland University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Vitamin D supplement
Controls
Arm Description
20,000 IU cholecalciferol p.o for the first 7 days, and weekly thereafter for 6 months
These patients had normal vitamin D levels and did not receive any treatment with vitamin D.
Outcomes
Primary Outcome Measures
Changes to depressive symptoms as assessed using the BDI-II score
Secondary Outcome Measures
Changes to serum liver function tests, as assessed using standard clinical-chemical assays
Changes to bone density, as assessed using Dexa scans
Full Information
NCT ID
NCT02359266
First Posted
February 4, 2015
Last Updated
February 6, 2015
Sponsor
Universität des Saarlandes
1. Study Identification
Unique Protocol Identification Number
NCT02359266
Brief Title
Vitamin D Improves Depression in Liver Patients
Acronym
CLDVitD
Official Title
Clinical Trial Investigating the Role of Vitamin D in the Treatment of Depression in Patients With Chronic Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität des Saarlandes
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Chronic Liver Disease
Keywords
Mood, Vitamin D deficiency, Adjuvant treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D supplement
Arm Type
Experimental
Arm Description
20,000 IU cholecalciferol p.o for the first 7 days, and weekly thereafter for 6 months
Arm Title
Controls
Arm Type
No Intervention
Arm Description
These patients had normal vitamin D levels and did not receive any treatment with vitamin D.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
cholecalciferol
Intervention Description
Given to patients with existing vitamin D deficiency
Primary Outcome Measure Information:
Title
Changes to depressive symptoms as assessed using the BDI-II score
Time Frame
3 and 6 months
Secondary Outcome Measure Information:
Title
Changes to serum liver function tests, as assessed using standard clinical-chemical assays
Time Frame
3 and 6 months
Title
Changes to bone density, as assessed using Dexa scans
Time Frame
at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Lammert, MD
Organizational Affiliation
Saarland University Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Caroline S Stokes, PhD
Organizational Affiliation
Saarland University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saarland University Medical Center
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Vitamin D Improves Depression in Liver Patients
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