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

Sponsor
Connie Thuree Nielsen, consultant, MD, ph.d (Other)
Overall Status
Completed
CT.gov ID
NCT01462058
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
5
Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
Mar 1, 2012

Arms and Interventions

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 Names:
  • Active

    		•
    Placebo Comparator: placebo

    one tablet of sugar pill per day for 12 weeks.

    Drug: Placebo
    Placebo, daily, 12 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Hamilton-29 [12 weeks]

      Change from baseline in Hamilton-29 at week 12

    Secondary Outcome Measures

    1. WHO-5 [12 weeks]

      Change from baseline in WHO-5 at week 12

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Mental Health Services Esbjerg Esbjerg Esbjerg N Denmark 6715

    Sponsors and Collaborators

    • Connie Thuree Nielsen, consultant, MD, ph.d

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Oct 28, 2011
    Last Update Posted:
    Mar 29, 2012
    Last Verified:
    Mar 1, 2012
    Keywords provided by Connie Thuree Nielsen, consultant, MD, ph.d, MD, ph.d, Region Syddanmark
    SPAQ
    Sigh-SAD
    Hamilton 29
    Vitamin D3
    p25(OH)D
    Additional relevant MeSH terms:
    Mood Disorders
    Seasonal Affective Disorder
    Vitamin D
    Cholecalciferol

    Study Results

    No Results Posted as of Mar 29, 2012