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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D supplement | Experimental | 20,000 IU cholecalciferol p.o for the first 7 days, and weekly thereafter for 6 months |
|
| Controls | No Intervention | These patients had normal vitamin D levels and did not receive any treatment with vitamin D. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | Given to patients with existing vitamin D deficiency |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes to depressive symptoms as assessed using the BDI-II score | 3 and 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Lammert, MD | Saarland University Medical Center | Study Chair |
| Caroline S Stokes, PhD | Saarland University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saarland University Medical Center | Homburg | Saarland | 66421 | Germany |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| D044342 |
| Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |