Can Vitamin D3 Supplementation Affect Treatment Outcomes in Patients With Depression

Depression Clinical Trial

— D3-vit-dep  

Official title:

Phase 4 Study of Vitamin D3 Supplementation for Outcomes in Patients With Unipolar Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01390662
• Other study ID #: 26992
• Secondary ID: 2010-023531-42
• Status: Recruiting
• Phase: Phase 4
• First received: July 5, 2011
• Last updated: March 27, 2012
• Start date: March 2011
• Est. completion date: December 2012

Study information

• Verified date: July 2011
• Source: Region Syddanmark
• Contact: Connie T Nielsen, PhD
• Phone: +4579182947
• Email: connie.thuroee.nielsen[@]psyk.regionsyddanmark.dk
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Dietary Supplement:
• Vitamin D3
one tablet of vitamin D3 70 µg pr. day, for 24 weeks.
• placebo
one tablet of sugar pill pr. day, for 24 weeks.

Locations

Country	Name	City	State
Denmark	Mental Health Services Esbjerg	Esbjerg
Denmark	Mental Health Services, Odense	Odense
Denmark	Mental Health Services Svendborg	Svendborg

Sponsors (1)

Lead Sponsor	Collaborator
Region Syddanmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton 17 item scale (Hamilton-17)	Change from baseline in Hamilton-17 at week 24	24 weeks	No
Secondary	WHO-Five Well-being Index (WHO-5)	Change from baseline in WHO-five at week 24	24 weeks	No