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Trial record 1 of 1 for:    NCT01462058
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The Role of Vitamin D Supplementation on Well Being and Symptoms of Depression During the Winter Season in Health Service Staff (D3-vit-SAD)

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ClinicalTrials.gov Identifier: NCT01462058
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : March 29, 2012
Sponsor:
Information provided by (Responsible Party):
Connie Thuree Nielsen, consultant, MD, ph.d, Region Syddanmark

Study Description
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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

Condition or disease Intervention/treatment Phase
Seasonal Affective Disorder Vitamin D3 Mental Health Dietary Supplement Dietary Supplement: Vitamin D3 Drug: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : October 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Vitamin D3
one tablet of vitamin D3 (70µg) per day for 12 weeks.
 Dietary Supplement: Vitamin D3
70µg Vitamin D3, daily, 12 weeks
Other Name: Active
Placebo Comparator: placebo
one tablet of sugar pill per day for 12 weeks.
 Drug: Placebo
Placebo, daily, 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Hamilton-29 [ Time Frame: 12 weeks ]
    Change from baseline in Hamilton-29 at week 12


Secondary Outcome Measures :
  1. WHO-5 [ Time Frame: 12 weeks ]
    Change from baseline in WHO-5 at week 12


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01462058


Locations
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Denmark
Mental Health Services Esbjerg
Esbjerg, Esbjerg N, Denmark, 6715
Sponsors and Collaborators
Connie Thuree Nielsen, consultant, MD, ph.d
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Connie Thuree Nielsen, consultant, MD, ph.d, MD, ph.d, Region Syddanmark
ClinicalTrials.gov Identifier: NCT01462058    
Other Study ID Numbers: ID-301115
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: March 29, 2012
Last Verified: March 2012
Keywords provided by Connie Thuree Nielsen, consultant, MD, ph.d, Region Syddanmark:
SPAQ
Sigh-SAD
Hamilton 29
Vitamin D3
p25(OH)D
Additional relevant MeSH terms:
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Mood Disorders
Seasonal Affective Disorder
Mental Disorders
Depressive Disorder
Vitamin D
Cholecalciferol
 Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents