Can Vitamin D3 Supplementation Affect Treatment Outcomes in Patients With Depression
NCT ID: NCT01390662
Last Updated: 2012-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2011-03-31
2012-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vitamin D3
one tablet of vitamin D3 (70µg) per day for 24 weeks.
Vitamin D3
one tablet of vitamin D3 70 µg pr. day, for 24 weeks.
placebo
one tablet of sugar pill per day for 24 weeks.
placebo
one tablet of sugar pill pr. day, for 24 weeks.
Interventions
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Vitamin D3
one tablet of vitamin D3 70 µg pr. day, for 24 weeks.
placebo
one tablet of sugar pill pr. day, for 24 weeks.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* tuberculosis
* bipolar affective disorder
* schizophrenia
* hypercalcemia
* hyperphosphatemia
* electroconvulsive treatment for the last 6 months
* primary diagnosis addiction
18 Years
65 Years
ALL
No
Sponsors
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Region Syddanmark
OTHER
Responsible Party
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Mental Health Services Esbjerg
Principal Investigators
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Connie T Nielsen, PhD
Role: STUDY_CHAIR
Mental Health Services Esbjerg
Erik Dahl, MD
Role: PRINCIPAL_INVESTIGATOR
Mental Health Services Svendborg
Tomas toft, PhD
Role: PRINCIPAL_INVESTIGATOR
Mental Health Services Odense
Locations
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Mental Health Services Esbjerg
Esbjerg, , Denmark
Mental Health Services, Odense
Odense, , Denmark
Mental Health Services Svendborg
Svendborg, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2010-023531-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
26992
Identifier Type: -
Identifier Source: org_study_id
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