Vitamin D Improves Depression in Liver Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression, Chronic Liver Disease

Intervention / Treatment
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* Dietary Supplement: Vitamin D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mood, Vitamin D deficiency, Adjuvant treatment