The Role of Vitamin D Supplementation on Well Being and Symptoms of Depression During the Winter Season in Health Service Staff (D3-vit-SAD)
Primary Purpose
Seasonal Affective Disorder, Vitamin D3, Mental Health
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Seasonal Affective Disorder focused on measuring SPAQ, Sigh-SAD, Hamilton 29, Vitamin D3, p25(OH)D
Eligibility 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
Sites / Locations
- Mental Health Services Esbjerg
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Vitamin D3
placebo
Arm Description
one tablet of vitamin D3 (70µg) per day for 12 weeks.
one tablet of sugar pill per day for 12 weeks.
Outcomes
Primary Outcome Measures
Hamilton-29
Change from baseline in Hamilton-29 at week 12
Secondary Outcome Measures
WHO-5
Change from baseline in WHO-5 at week 12
Full Information
NCT ID
NCT01462058
First Posted
October 26, 2011
Last Updated
March 28, 2012
Sponsor
Connie Thuree Nielsen, consultant, MD, ph.d
1. Study Identification
Unique Protocol Identification Number
NCT01462058
Brief Title
The Role of Vitamin D Supplementation on Well Being and Symptoms of Depression During the Winter Season in Health Service Staff
Acronym
D3-vit-SAD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Connie Thuree Nielsen, consultant, MD, ph.d
4. Oversight
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Affective Disorder, Vitamin D3, Mental Health, Dietary Supplement
Keywords
SPAQ, Sigh-SAD, Hamilton 29, Vitamin D3, p25(OH)D
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D3
Arm Type
Active Comparator
Arm Description
one tablet of vitamin D3 (70µg) per day for 12 weeks.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
one tablet of sugar pill per day for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Active
Intervention Description
70µg Vitamin D3, daily, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, daily, 12 weeks
Primary Outcome Measure Information:
Title
Hamilton-29
Description
Change from baseline in Hamilton-29 at week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
WHO-5
Description
Change from baseline in WHO-5 at week 12
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Mental Health Services Esbjerg
City
Esbjerg
State/Province
Esbjerg N
ZIP/Postal Code
6715
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
25125215
Citation
Frandsen TB, Pareek M, Hansen JP, Nielsen CT. Vitamin D supplementation for treatment of seasonal affective symptoms in healthcare professionals: a double-blind randomised placebo-controlled trial. BMC Res Notes. 2014 Aug 14;7:528. doi: 10.1186/1756-0500-7-528.
Results Reference
derived
Learn more about this trial
The Role of Vitamin D Supplementation on Well Being and Symptoms of Depression During the Winter Season in Health Service Staff
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