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

NCT ID: NCT01462058

Last Updated: 2012-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Seasonal Affective Disorder Vitamin D3 Mental Health Dietary Supplement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D3

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

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

70µg Vitamin D3, daily, 12 weeks

placebo

one tablet of sugar pill per day for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, daily, 12 weeks

Interventions

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Vitamin D3

70µg Vitamin D3, daily, 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo, daily, 12 weeks

Intervention Type DRUG

Other Intervention Names

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Active

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Connie Thuree Nielsen, consultant, MD, ph.d

OTHER

Sponsor Role lead

Responsible Party

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Connie Thuree Nielsen, consultant, MD, ph.d

MD, ph.d

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Mental Health Services Esbjerg

Esbjerg, Esbjerg N, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 25125215 (View on PubMed)

Other Identifiers

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ID-301115

Identifier Type: -

Identifier Source: org_study_id

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