The Role of Vitamin D Supplementation on Well Being and Symptoms of Depression During the Winter Season in Health Service Staff (D3-vit-SAD)

Connie Thuree Nielsen, consultant, MD, ph.d

Status and phase: Completed; Phase 4

Conditions: Vitamin D3; Seasonal Affective Disorder; Dietary Supplement; Mental Health

Treatments: Dietary Supplement: Vitamin D3; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01462058

ID-301115

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Vitamin D3

Active Comparator group

Description:

one tablet of vitamin D3 (70µg) per day for 12 weeks.

Treatment:

Dietary Supplement: Vitamin D3

placebo

Placebo Comparator group

Description:

one tablet of sugar pill per day for 12 weeks.

Treatment:

Drug: Placebo