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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by:
Region Syddanmark

Tracking Information
First Submitted Date  ICMJE July 5, 2011
First Posted Date  ICMJE July 11, 2011
Last Update Posted Date March 28, 2012
Study Start Date  ICMJE March 2011
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2011)
Hamilton 17 item scale (Hamilton-17) [ Time Frame: 24 weeks ]
Change from baseline in Hamilton-17 at week 24
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2011)
WHO-Five Well-being Index (WHO-5) [ Time Frame: 24 weeks ]
Change from baseline in WHO-five at week 24
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Can Vitamin D3 Supplementation Affect Treatment Outcomes in Patients With Depression
Official Title  ICMJE Phase 4 Study of Vitamin D3 Supplementation for Outcomes in Patients With Unipolar Depression
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 8, 2011)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01390662
Other Study ID Numbers  ICMJE 26992
2010-023531-42 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Connie Thuroee Nielsen, consultant,PhD, Mental Health Services Esbjerg
Study Sponsor  ICMJE Region Syddanmark
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Region Syddanmark
Verification Date July 2011

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