Vitamin D Improves Depression in Liver Patients (CLDVitD)

Universität des Saarlandes

Status: Completed

Conditions: Chronic Liver Disease; Depression

Treatments: Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT02359266

SaarlandU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 2 patient groups

Vitamin D supplement

Experimental group

Description:

20,000 IU cholecalciferol p.o for the first 7 days, and weekly thereafter for 6 months

Treatment:

Dietary Supplement: Vitamin D

Controls

No Intervention group

Description:

These patients had normal vitamin D levels and did not receive any treatment with vitamin D.