DepressionPhase 4D3-vit-depNCT01390662
Can Vitamin D3 Supplementation Affect Treatment Outcomes in Patients With Depression
A Phase 4 study testing Vitamin D3 in people with Depression, run by Region Syddanmark at 3 sites in Denmark.
Trial summary
The purpose of this study is to investigate whether patients with depression should be offered vitamin D supplements, or it has no significance in relation to treatment outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 3 sitesDenmark
- Study dates
- Mar 2011to Dec 2012
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis unipolar depression
Who cannot join
- clinical diagnosis sarcoidoses
- tuberculosis
- bipolar affective disorder
- schizophrenia
- hypercalcemia
- hyperphosphatemia
- electroconvulsive treatment for the last 6 months
- primary diagnosis addiction
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites, 3 recruiting
- Recruiting
Mental Health Services Esbjerg
Esbjerg, DK-6715
Connie T Nielsen, PhD, +4579182947, connie.thuroee.nielsen@psyk.regionsyddanmark.dk
Connie T Nielsen, PhD
- Recruiting
Mental Health Services, Odense
Odense, Dk-5000
Tomas Toft, Ph.D, +4565413300, tomas.toft@psyk.regionsyddanmark.dk
Tomas Toft, PhD
- Recruiting
Mental Health Services Svendborg
Svendborg, DK-5700
Erik Dahl, MD, 63201051, Erik.dahl@psyk.regionsyddanmark.dk
Erik Dahl, MD
About this study
Official title: Phase 4 Study of Vitamin D3 Supplementation for Outcomes in Patients With Unipolar Depression
The purpose of this study is to investigate whether patients with depression should be offered vitamin D supplements, or it has no significance in relation to treatment outcomes.
Read the detailed description
Vitamin D3 is produced in the skin after exposure to ultraviolet B light from the sun. Vitamin D3 is metabolised sequential in the liver into 25-hydroxy-vitamin D [25(OH)D], which is the storage form of vitamin D in the body, and then in the kidney into the steroid hormone, 1a,25-dihydroxyvitamin 1a,25-dihydroxyvitamin D [1,25(OH)2D].
At higher latitudes ultraviolet B light is stopped by the atmosphere during winter season. Half of Danes have low levels of [25(OH)D] in the blood and especially in the early spring months the levels of [25(OH)D] are low. In addition, Vitamin D3 is absorbed through the gut from vitamin D-rich food sources. But several studies show that it is not possible through a recommended diet, which consists of 300 g of fish per week to consume adequate amounts of vitamin D3.
New research suggests link between vitamin D3 and brain function.In the Central Nervous System (CNS) there are specific nuclear receptors for 1,25(OH)2D (VDR) and the enzymes necessary for the hydroxylation of 25(OH)D to 1,25(OH)2D are also present in CNS.
In clinical studies, low serum levels of 25(OH)D, have been associated with reduced cognitive function, anxiety and depression.
The objective of this randomized clinical trial is to investigate whether patients with depression should be offered vitamin D3 supplements, or it has no significance in relation to treatment outcomes.
The study is carried out in Mental Health Services in the Region of Southern Denmark for 24 weeks and offered to patients being treated for depression (treatment as usual) plus 70μg vitamin D3 or placebo.
- Conditions
- Depression
- Being tested
- Vitamin D3, placebo
- Keywords
- serum 25-hydroxyvitamin d,vitamin D supplement, depression,, parathyroid hormone
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
one tablet of vitamin D3 70 µg pr. day, for 24 weeks.
placeboDietary supplement
one tablet of sugar pill pr. day, for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Active comparator | one tablet of vitamin D3 (70µg) per day for 24 weeks. Receives: Dietary Supplement: Vitamin D3 |
| placebo | Placebo comparator | one tablet of sugar pill per day for 24 weeks. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton 17 item scale (Hamilton-17)
Change from baseline in Hamilton-17 at week 24
Measured: 24 weeks
Secondary outcomes (1)
WHO-Five Well-being Index (WHO-5)
Change from baseline in WHO-five at week 24
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Syddanmark
- Sponsor type
- University, hospital or other
- Investigators
- Connie T Nielsen, PhD, Study chair, Mental Health Services EsbjergErik Dahl, MD, Principal investigator, Mental Health Services SvendborgTomas toft, PhD, Principal investigator, Mental Health Services Odense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390662
- Sponsor's protocol ID
- 26992
- Other IDs
- 2010-023531-42
- Acronym
- D3-vit-dep
- Status last verified
- Jul 2011
- First submitted
- 5 Jul 2011
- Last updated
- 28 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hansen JP, Pareek M, Hvolby A, Schmedes A, Toft T, Dahl E, Nielsen CT. Vitamin D3 supplementation and treatment outcomes in patients with depression (D3-vit-dep). BMC Res Notes. 2019 Apr 3;12(1):203. doi: 10.1186/s13104-019-4218-z.
PubMed 30944021
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Vitamin D3 Supplementation for Outcomes in Patients With Unipolar Depression
- ClinicalTrials.gov ID
- NCT01390662
- Acronym / sponsor ID
- D3-vit-dep / 26992
- Conditions
- Depression
- Keywords
- serum 25-hydroxyvitamin d,vitamin D supplement, depression,, parathyroid hormone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Region SyddanmarkUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 11 Jul 2011 (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.
The purpose of this study is to investigate whether patients with depression should be offered vitamin D supplements, or it has no significance in relation to treatment outcomes.
Detailed description
Vitamin D3 is produced in the skin after exposure to ultraviolet B light from the sun. Vitamin D3 is metabolised sequential in the liver into 25-hydroxy-vitamin D [25(OH)D], which is the storage form of vitamin D in the body, and then in the kidney into the steroid hormone, 1a,25-dihydroxyvitamin 1a,25-dihydroxyvitamin D [1,25(OH)2D].
At higher latitudes ultraviolet B light is stopped by the atmosphere during winter season. Half of Danes have low levels of [25(OH)D] in the blood and especially in the early spring months the levels of [25(OH)D] are low. In addition, Vitamin D3 is absorbed through the gut from vitamin D-rich food sources. But several studies show that it is not possible through a recommended diet, which consists of 300 g of fish per week to consume adequate amounts of vitamin D3.
New research suggests link between vitamin D3 and brain function.In the Central Nervous System (CNS) there are specific nuclear receptors for 1,25(OH)2D (VDR) and the enzymes necessary for the hydroxylation of 25(OH)D to 1,25(OH)2D are also present in CNS.
In clinical studies, low serum levels of 25(OH)D, have been associated with reduced cognitive function, anxiety and depression.
The objective of this randomized clinical trial is to investigate whether patients with depression should be offered vitamin D3 supplements, or it has no significance in relation to treatment outcomes.
The study is carried out in Mental Health Services in the Region of Southern Denmark for 24 weeks and offered to patients being treated for depression (treatment as usual) plus 70μg vitamin D3 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Active comparator | Dietary Supplement: Vitamin D3one tablet of vitamin D3 (70µg) per day for 24 weeks. |
| placebo | Placebo comparator | Dietary Supplement: placeboone tablet of sugar pill per day for 24 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical diagnosis unipolar depression
Key exclusion criteria (8 listed)
- clinical diagnosis sarcoidoses
- tuberculosis
- bipolar affective disorder
- schizophrenia
- hypercalcemia
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 D3one tablet of vitamin D3 70 µg pr. day, for 24 weeks. | Dietary supplement | Vitamin D3 |
| placeboone tablet of sugar pill pr. day, for 24 weeks. | Dietary supplement | placebo |
Primary outcome
Hamilton 17 item scale (Hamilton-17)
Time frame: 24 weeks
Change from baseline in Hamilton-17 at week 24
1 secondary outcome
WHO-Five Well-being Index (WHO-5)
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2012.
- Derived from this study: PubMed 30944021Hansen JP, Pareek M, Hvolby A, Schmedes A, Toft T, Dahl E, Nielsen CT. Vitamin D3 supplementation and treatment outcomes in patients with depression (D3-vit-dep). BMC Res Notes. 2019 Apr 3;12(1):203. doi: 10.1186/s13104-019-4218-z.
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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.
Connie T Nielsen, PhD study chair
Mental Health Services Esbjerg
Erik Dahl, MD principal investigator
Mental Health Services Svendborg
Tomas toft, PhD principal investigator
Mental Health Services Odense
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D3 in people with Depression, run by Region Syddanmark at 3 sites in Denmark.
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 1 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: status not confirmed, as of the sponsor's last update on 28 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Connie T Nielsen, PhD (+4579182947, connie.thuroee.nielsen@psyk.regionsyddanmark.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton 17 item scale (Hamilton-17) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01390662, which also lists 1 linked publication.
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 28 Mar 2012.