DepressionCLDVitDNCT02359266
Vitamin D Improves Depression in Liver Patients
A study testing Vitamin D in people with Depression and Chronic Liver Disease, run by Universität des Saarlandes at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Chronic Liver Disease
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women
- over 18 years of age
- chronic liver disease
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial Investigating the Role of Vitamin D in the Treatment of Depression in Patients With Chronic Liver Disease
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.
Read the 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.
- Conditions
- Depression, Chronic Liver Disease
- Being tested
- Vitamin D
- Keywords
- Mood, Vitamin D deficiency, Adjuvant treatment
- Medical subject headings
- Depression, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Also called cholecalciferol
Given to patients with existing vitamin D deficiency
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D supplement | Experimental | 20,000 IU cholecalciferol p.o for the first 7 days, and weekly thereafter for 6 months Receives: Dietary Supplement: Vitamin D |
| Controls | No intervention | These patients had normal vitamin D levels and did not receive any treatment with vitamin D. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes to depressive symptoms as assessed using the BDI-II score
Measured: 3 and 6 months
Secondary outcomes (2)
Changes to serum liver function tests, as assessed using standard clinical-chemical assays
Measured: 3 and 6 months
Changes to bone density, as assessed using Dexa scans
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startDec 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Caroline Stokes, Universität des Saarlandes
- Investigators
- Frank Lammert, MD, Study chair, Saarland University Medical CenterCaroline S Stokes, PhD, Principal investigator, Saarland University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359266
- Sponsor's protocol ID
- SaarlandU
- Acronym
- CLDVitD
- Status last verified
- Feb 2015
- First submitted
- 4 Feb 2015
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Investigating the Role of Vitamin D in the Treatment of Depression in Patients With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT02359266
- Acronym / sponsor ID
- CLDVitD / SaarlandU
- Conditions
- Depression, Chronic Liver Disease
- Keywords
- Mood, Vitamin D deficiency, Adjuvant treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D supplement | Experimental | Dietary Supplement: Vitamin D20,000 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men and women
- over 18 years of age
- chronic liver disease
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: cholecalciferolGiven to patients with existing vitamin D deficiency | Dietary supplement | Vitamin D supplement |
Primary outcome
Changes to depressive symptoms as assessed using the BDI-II score
Time frame: 3 and 6 months
2 secondary outcomes
Changes to serum liver function tests, as assessed using standard clinical-chemical assays
Time frame: 3 and 6 months
Changes to bone density, as assessed using Dexa scans
Time frame: at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Lammert, MD study chair
Saarland University Medical Center
Caroline S Stokes, PhD principal investigator
Saarland University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Depression and Chronic Liver Disease, run by Universität des Saarlandes at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes to depressive symptoms as assessed using the BDI-II score (time frame: 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2015.