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

This study is currently recruiting participants.

Verified July 2011 by Region Syddanmark

Sponsor:

Information provided by:

Region Syddanmark

ClinicalTrials.gov Identifier:

NCT01390662

First received: July 5, 2011

Last updated: March 27, 2012

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 5, 2011

Last Updated Date

March 27, 2012

Start Date ^ICMJE

March 2011

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hamilton 17 item scale (Hamilton-17) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Change from baseline in Hamilton-17 at week 24

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01390662 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Arm (s)

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 *

Not Provided

* 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

Recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Connie T Nielsen, PhD	+4579182947	connie.thuroee.nielsen@psyk.regionsyddanmark.dk
Contact: Anne-Lene Kjeldmann	+4579182947	anne-lene.kjeldmann@psyk.regionsyddanmark.dk

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01390662

Other Study ID Numbers ^ICMJE

26992, 2010-023531-42

Has Data Monitoring Committee

Yes

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

Information Provided By

Region Syddanmark

Verification Date

July 2011

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

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