The Role of Vitamin D Supplementation on Well Being and Symptoms of Depression During the Winter Season in Health Service Staff (D3-vit-SAD)
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|ClinicalTrials.gov Identifier: NCT01462058|
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : March 29, 2012
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|Condition or disease||Intervention/treatment||Phase|
|Seasonal Affective Disorder Vitamin D3 Mental Health Dietary Supplement||Dietary Supplement: Vitamin D3 Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
Active Comparator: Vitamin D3
one tablet of vitamin D3 (70µg) per day for 12 weeks.
Dietary Supplement: Vitamin D3
70µg Vitamin D3, daily, 12 weeks
Other Name: Active
Placebo Comparator: placebo
one tablet of sugar pill per day for 12 weeks.
Placebo, daily, 12 weeks
- Hamilton-29 [ Time Frame: 12 weeks ]Change from baseline in Hamilton-29 at week 12
- WHO-5 [ Time Frame: 12 weeks ]Change from baseline in WHO-5 at week 12
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Health service staff and employee in the Region of Southern Denmark.
- Tendency to depressive symptoms in the winter season SPAQ>7.
- clinical diagnosis sarcoidoses
- bipolar affective disorder
- reduced kidney function
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01462058
|Mental Health Services Esbjerg|
|Esbjerg, Esbjerg N, Denmark, 6715|
|Responsible Party:||Connie Thuree Nielsen, consultant, MD, ph.d, MD, ph.d, Region Syddanmark|
|Other Study ID Numbers:||
|First Posted:||October 28, 2011 Key Record Dates|
|Last Update Posted:||March 29, 2012|
|Last Verified:||March 2012|
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