Does vitamin D supplementation affect well-being and symptoms of depression during the Winter season in health service staff?

Phase 1

• Conditions: Seasonal affective disorder.; MedDRA version: 14.1Level: PTClassification code 10039775Term: Seasonal affective disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-002585-20-DK
• Lead Sponsor: Psykiatrien i Region Syddanmark

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-22
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

Employed at either Sydvestjysk Sygehus or Psykiatrien i Region Syddanmark, Esbjerg, Denmark.
Seasonal Pattern Assessment Questionnaire (SPAQ-SAD) score above 11.
Negative urine hCG test in women of childbearing potential.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 172
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Fulfilled ICD-10 criteria for diseases F20-29 and F31.
Sarcoidosis.
Tuberculosis.
Decreased kidney function measured as estimated GFR (4-variable MDRD equation) < 60 ml per minute.
Increased plasma ionized calcium concentration above 1,40 mmoles per liter.
Increased plasma phosphate concentration above 1,50 mmoles per liter for women, above 1,60 mmoles per liter for men below 50 years of age and above 1,35 mmoles per liter for men equal to and above 50 years of age.
Plasma concentration of 25-hydroxy-vitamin D3 below 10 nmoles per liter or above 160 nmoles per liter.
Hyperparathyroidism measured as PTH concentration above 9,2 pmoles per liter.
Pregnancy or wanted pregnancy.
Nursing women.
Already participated in the trial.
Daily intake of vitamin D3 above 10 micrograms.
Allergy towards tablet contents.
No informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): World Health Organization Five Well Being Index (WHO-5) score.<br>Depression Self-Assessment Inventory (SIGH-SAD-SA) score.<br>Plasma concentration of 25-hydroxy-vitamin D3.<br>;Timepoint(s) of evaluation of this end point: 0 and 3 months for WHO-5 and SIGH-SAD.<br>0 and 3 months for 25-hydroxy-vitamin D3.;Main Objective: To investigate whether or not vitamin D supplementation is better than placebo in preventing symptoms of depression in health service staff.;Secondary Objective: To investigate whether or not there is a correlation between symptoms of depression and Winter depression in health service staff and the plasma concentration of 25-hydroxy-vitamin D3.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Correlation between SIGH-SAD-SA and WHO-5 score and the plasma concentration of 25-hydroxy-vitamin D3 in the two groups.<br>Whether or not the total number of sick days are fewer in the vitamin D receiving group.;Timepoint(s) of evaluation of this end point: 3 months.