Clinical trial NCT01462058: The Role of Vitamin D Supplementation on Well Being and Symptoms of Depression During the Winter Season in Health Service Staff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seasonal Affective Disorder
Vitamin D3
Mental Health
Dietary Supplement
Keywords: SPAQ
Sigh-SAD
Hamilton 29
Vitamin D3
p25(OH)D
Lead sponsor: Region Syddanmark
Sponsor class: OTHER
First posted: 2011-10-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate whether vitamin D3 (70 micrograms) is better than placebo in preventing depression symptoms among employees in health care

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 indoor employees, with tendency to depressive symptoms in the winter season, should be offered vitamin D3 supplements during the Winter season, or it has no significance in relation prevent depressive symptoms.

The study is carried out in the winter season in the Region of Southern Denmark for 12 weeks and offered to health service staff, who have a tendency for depressive symptoms in the winter season.

Eligibility criteria: Inclusion Criteria:

* Health service staff and employee in the Region of Southern Denmark.
* Tendency to depressive symptoms in the winter season SPAQ\>7.

Exclusion Criteria:

* clinical diagnosis sarcoidoses
* tuberculosis
* bipolar affective disorder
* schizophrenia
* hypercalcemia
* hyperphosphatemia
* pregnancy
* hyperparathyroidism
* reduced kidney function

Primary outcomes:
measure: Hamilton-29
timeFrame: 12 weeks
Secondary outcomes:
measure: WHO-5
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Mental Health Services Esbjerg
state: Esbjerg N
Study officials:
References:
citation: Frandsen TB, Pareek M, Hansen JP, Nielsen CT. Vitamin D supplementation for treatment of seasonal affective symptoms in healthcare professionals: a double-blind randomised placebo-controlled trial. BMC Res Notes. 2014 Aug 14;7:528. doi: 10.1186/1756-0500-7-528.