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Completed

NCT Number: NCT02359266

Vitamin D Improves Depression in Liver Patients

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.

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Key information

Conditions

Depression Avitaminosis Behavior Behavioral Symptoms Chronic Liver Disease Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saarland University Medical Center

Homburg, Saarland, 66421, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

Given to patients with existing vitamin D deficiency

Other names: cholecalciferol

Primary outcomes

  1. Changes to depressive symptoms as assessed using the BDI-II score

    Time frame: 3 and 6 months

Secondary outcomes

  1. Changes to serum liver function tests, as assessed using standard clinical-chemical assays

    Time frame: 3 and 6 months

  2. Changes to bone density, as assessed using Dexa scans

    Time frame: at 12 months

Sponsors and collaborators

Lead sponsor

Universität des Saarlandes

Other

Registry information

Official study title

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

Acronym: CLDVitD

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 9, 2015
Registry last updated
Feb 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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