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

The role of vitamin D supplementation on well-being and symptoms of depression during the Winter season in health service staff.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002585-20-DK

Enrollment

172

Registered

2011-08-22

Start date

2011-09-13

Completion date

Unknown

Last updated

2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal affective disorder. MedDRA version: 14.1 Level: PT Classification code 10039775 Term: Seasonal affective disorder System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: Cholecalciferol 70 mikrog. Product Name: Cholecalciferol 70 mikrog Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): World Health Organization Five Well Being Index (WHO-5) score. Depression Self-Assessment Inventory (SIGH-SAD-SA) score. Plasma concentration of 25-hydroxy-vitamin D3. ;Timepoint(s) of evaluation of this end point: 0 and 3 months for WHO-5 and SIGH-SAD. 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.	—

Measure

Time frame

Primary end point(s): World Health Organization Five Well Being Index (WHO-5) score. Depression Self-Assessment Inventory (SIGH-SAD-SA) score. Plasma concentration of 25-hydroxy-vitamin D3. ;Timepoint(s) of evaluation of this end point: 0 and 3 months for WHO-5 and SIGH-SAD. 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.

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Secondary

Measure	Time frame
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. 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.	—

Countries

Denmark

Contacts

Public ContactVitamin D til sundhedspersonale

Psykiatrien i Region Syddanmark

connie.thuroee.nielsen@psyk.regionsyddanmark.dk+4579182947

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 19, 2026