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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02359266
Other study ID # SaarlandU
Secondary ID
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


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
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