NCT02359266

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
Last Updated

February 9, 2015

Status Verified

February 1, 2015

Enrollment Period

2 years

First QC Date

February 4, 2015

Last Update Submit

February 6, 2015

Conditions

DepressionChronic Liver Disease

Keywords

MoodVitamin D deficiencyAdjuvant treatment

Outcome Measures

Primary Outcomes (1)

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

    3 and 6 months

Secondary Outcomes (2)

  • 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

Study Arms (2)

Vitamin D supplement

EXPERIMENTAL

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

Dietary Supplement: Vitamin D

Controls

NO INTERVENTION

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

Interventions

Vitamin DDIETARY_SUPPLEMENT

Given to patients with existing vitamin D deficiency

Also known as: cholecalciferol
Vitamin D supplement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and women
  • over 18 years of age
  • chronic liver disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saarland University Medical Center

Homburg, Saarland, 66421, Germany

Location

MeSH Terms

Conditions

DepressionVitamin D Deficiency

Interventions

Vitamin DCholecalciferol

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipids

Study Officials

  • Frank Lammert, MD

    Saarland University Medical Center

    STUDY CHAIR

  • Caroline S Stokes, PhD

    Saarland University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 9, 2015

Study Start

December 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 9, 2015

Record last verified: 2015-02

Locations

DE(1)