Can Vitamin D3 Supplementation Affect Treatment Outcomes in Patients With Depression (D3-vit-dep)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Region Syddanmark.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Region Syddanmark
ClinicalTrials.gov Identifier:
NCT01390662
First received: July 5, 2011
Last updated: March 27, 2012
Last verified: July 2011

July 5, 2011
March 27, 2012
March 2011
May 2012   (final data collection date for primary outcome measure)
Hamilton 17 item scale (Hamilton-17) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change from baseline in Hamilton-17 at week 24
Same as current
Complete list of historical versions of study NCT01390662 on ClinicalTrials.gov Archive Site
WHO-Five Well-being Index (WHO-5) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change from baseline in WHO-five at week 24
Same as current
Not Provided
Not Provided
 
Can Vitamin D3 Supplementation Affect Treatment Outcomes in Patients With Depression
Phase 4 Study of Vitamin D3 Supplementation for Outcomes in Patients With Unipolar Depression

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • Dietary Supplement: Vitamin D3
    one tablet of vitamin D3 70 µg pr. day, for 24 weeks.
  • Dietary Supplement: placebo
    one tablet of sugar pill pr. day, for 24 weeks.
  • Active Comparator: Vitamin D3
    one tablet of vitamin D3 (70µg) per day for 24 weeks.
    Intervention: Dietary Supplement: Vitamin D3
  • Placebo Comparator: placebo
    one tablet of sugar pill per day for 24 weeks.
    Intervention: Dietary Supplement: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Connie T Nielsen, PhD +4579182947 connie.thuroee.nielsen@psyk.regionsyddanmark.dk
Contact: Anne-Lene Kjeldmann +4579182947 anne-lene.kjeldmann@psyk.regionsyddanmark.dk
Denmark
 
NCT01390662
26992, 2010-023531-42
Yes
Connie Thuroee Nielsen, consultant,PhD, Mental Health Services Esbjerg
Region Syddanmark
Not Provided
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
Region Syddanmark
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP