Clinical trial NCT01390662: Can Vitamin D3 Supplementation Affect Treatment Outcomes in Patients With Depression
Official title: Phase 4 Study of Vitamin D3 Supplementation for Outcomes in Patients With Unipolar Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Depression
Keywords: serum 25-hydroxyvitamin d,vitamin D supplement, depression,
parathyroid hormone
Lead sponsor: Region Syddanmark
Sponsor class: OTHER
First posted: 2011-07-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria

* clinical diagnosis unipolar depression

Exclusion Criteria:

* clinical diagnosis sarcoidoses
* tuberculosis
* bipolar affective disorder
* schizophrenia
* hypercalcemia
* hyperphosphatemia
* electroconvulsive treatment for the last 6 months
* primary diagnosis addiction

Primary outcomes:
measure: Hamilton 17 item scale (Hamilton-17)
timeFrame: 24 weeks
Secondary outcomes:
measure: WHO-Five Well-being Index (WHO-5)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Mental Health Services Esbjerg
city: Odense
country: Denmark
facility: Mental Health Services, Odense
city: Svendborg
country: Denmark
facility: Mental Health Services Svendborg
Study officials:
affiliation: Mental Health Services Esbjerg
name: Connie T Nielsen, PhD
role: STUDY_CHAIR
affiliation: Mental Health Services Svendborg
name: Erik Dahl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mental Health Services Odense
name: Tomas toft, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.