Can Vitamin D3 Supplementation Affect Treatment Outcomes in Patients With Depression (D3-vit-dep)
|ClinicalTrials.gov Identifier: NCT01390662|
Recruitment Status : Unknown
Verified July 2011 by Region Syddanmark.
Recruitment status was: Recruiting
First Posted : July 11, 2011
Last Update Posted : March 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Depression||Dietary Supplement: Vitamin D3 Dietary Supplement: 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 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase 4 Study of Vitamin D3 Supplementation for Outcomes in Patients With Unipolar Depression|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||December 2012|
Active Comparator: Vitamin D3
one tablet of vitamin D3 (70µg) per day for 24 weeks.
Dietary Supplement: Vitamin D3
one tablet of vitamin D3 70 µg pr. day, for 24 weeks.
Placebo Comparator: placebo
one tablet of sugar pill per day for 24 weeks.
Dietary Supplement: placebo
one tablet of sugar pill pr. day, for 24 weeks.
- Hamilton 17 item scale (Hamilton-17) [ Time Frame: 24 weeks ]Change from baseline in Hamilton-17 at week 24
- WHO-Five Well-being Index (WHO-5) [ Time Frame: 24 weeks ]Change from baseline in WHO-five at week 24
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390662
|Contact: Connie T Nielsen, PhDfirstname.lastname@example.org|
|Contact: Anne-Lene Kjeldmannemail@example.com|
|Mental Health Services Esbjerg||Recruiting|
|Esbjerg, Denmark, DK-6715|
|Contact: Connie T Nielsen, PhD +4579182947 firstname.lastname@example.org|
|Principal Investigator: Connie T Nielsen, PhD|
|Mental Health Services, Odense||Recruiting|
|Odense, Denmark, Dk-5000|
|Contact: Tomas Toft, Ph.D +4565413300 email@example.com|
|Principal Investigator: Tomas Toft, PhD|
|Mental Health Services Svendborg||Recruiting|
|Svendborg, Denmark, DK-5700|
|Contact: Erik Dahl, MD 63201051 Erik.firstname.lastname@example.org|
|Principal Investigator: Erik Dahl, MD|
|Study Chair:||Connie T Nielsen, PhD||Mental Health Services Esbjerg|
|Principal Investigator:||Erik Dahl, MD||Mental Health Services Svendborg|
|Principal Investigator:||Tomas toft, PhD||Mental Health Services Odense|