Vitamin D Improves Depression in Liver Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02359266

Acronym

CLDVitD

Enrollment

111

Registered

2015-02-09

Start date

2011-12-31

Completion date

2013-12-31

Last updated

2015-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Liver Disease, Depression

Keywords

Mood, Vitamin D deficiency, Adjuvant treatment

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.

Interventions

DIETARY_SUPPLEMENTVitamin D

Given to patients with existing vitamin D deficiency

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026