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

Phase 4

Completed

• Conditions: Seasonal Affective Disorder; Vitamin D3; Mental Health; Dietary Supplement
• Interventions: Dietary Supplement: Vitamin D3; Drug: Placebo

• Registration Number: NCT01462058
• Lead Sponsor: Connie Thuree Nielsen, consultant, MD, ph.d

Brief 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

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 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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-26
• Study First Submitted QC: 2011-10-27
• Study First Posted: 2011-10-28
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-28
• Last Update Posted: 2012-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D3	Vitamin D3	one tablet of vitamin D3 (70µg) per day for 12 weeks.
placebo	Placebo	one tablet of sugar pill per day for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Hamilton-29	12 weeks	Change from baseline in Hamilton-29 at week 12

Secondary Outcome Measures

Name	Time	Method
WHO-5	12 weeks	Change from baseline in WHO-5 at week 12

Trial Locations

Locations (1)

Mental Health Services Esbjerg; 🇩🇰 Esbjerg, Esbjerg N, Denmark