The Role of Vitamin D Supplementation on Well Being and Symptoms of Depression During the Winter Season in Health Service Staff

Mental Health Clinical Trial

— D3-vit-SAD  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01462058
• Other study ID #: ID-301115
• Status: Completed
• Phase: Phase 4
• First received: October 26, 2011
• Last updated: March 28, 2012
• Start date: October 2011
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Region Syddanmark
• Contact: n/a
• 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 vitamin D3 (70 micrograms) is better than placebo in preventing depression symptoms among employees in health care

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 indoor employees, with tendency to depressive symptoms in the winter season, should be offered vitamin D3 supplements during the Winter season, or it has no significance in relation prevent depressive symptoms.

The study is carried out in the winter season in the Region of Southern Denmark for 12 weeks and offered to health service staff, who have a tendency for depressive symptoms in the winter season.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Health service staff and employee in the Region of Southern Denmark.

• Tendency to depressive symptoms in the winter season SPAQ>7.

Exclusion Criteria:

• clinical diagnosis sarcoidoses

• tuberculosis

• bipolar affective disorder

• schizophrenia

• hypercalcemia

• hyperphosphatemia

• pregnancy

• hyperparathyroidism

• reduced kidney function

Study Design

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

Related Conditions & MeSH terms

• Dietary Supplement
• Mental Health
• Mood Disorders
• Seasonal Affective Disorder
• Vitamin D3

Intervention

Dietary Supplement:
• Vitamin D3
70µg Vitamin D3, daily, 12 weeks

Drug:
• Placebo
Placebo, daily, 12 weeks

Locations

Country	Name	City	State
Denmark	Mental Health Services Esbjerg	Esbjerg	Esbjerg N

Sponsors (1)

Lead Sponsor	Collaborator
Connie Thuree Nielsen, consultant, MD, ph.d

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton-29	Change from baseline in Hamilton-29 at week 12	12 weeks	Yes
Secondary	WHO-5	Change from baseline in WHO-5 at week 12	12 weeks	Yes