CLDVitD: Vitamin D Improves Depression in Liver Patients

Sponsor

Universität des Saarlandes (Other)

Overall Status

Completed

CT.gov ID

NCT02359266

Collaborator

(none)

111

Enrollment

Location

Arms

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Chronic Liver Disease	Dietary Supplement: Vitamin D	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

111 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Vitamin D supplement

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

Dietary Supplement: Vitamin D

Given to patients with existing vitamin D deficiency

Other Names:

cholecalciferol

No Intervention: Controls

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

Outcome Measures

Primary Outcome Measures

Changes to depressive symptoms as assessed using the BDI-II score [3 and 6 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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