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Completed

NCT Number: NCT01462058

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

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

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Key information

Conditions

Seasonal Affective Disorder Behavior Depressive Disorder Dietary Supplement Mental Disorders Mental Health Mood Disorders Personal Satisfaction Psychological Well-Being Vitamin D3

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mental Health Services Esbjerg

Esbjerg, Esbjerg N, 6715, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Dietary Supplement

70µg Vitamin D3, daily, 12 weeks

Other names: Active

Placebo

Drug

Placebo, daily, 12 weeks

Primary outcomes

  1. Hamilton-29

    Time frame: 12 weeks

    Change from baseline in Hamilton-29 at week 12

Secondary outcomes

  1. WHO-5

    Time frame: 12 weeks

    Change from baseline in WHO-5 at week 12

Sponsors and collaborators

Lead sponsor

Connie Thuree Nielsen, consultant, MD, ph.d

Other

Registry information

Acronym: D3-vit-SAD

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 28, 2011
Registry last updated
Mar 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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