The role of vitamin D supplementation on symptoms in patients treated for depression. A double-blind randomized trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023531-42-DK

Enrollment

400

Registered

2011-02-09

Start date

2011-02-04

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

Depression as defined by fulfilled ICD-10 criteria for diseases F32.1-3, F33.1-3. MedDRA version: 14.0 Level: PT Classification code 10057840 Term: Major depression 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: Depression as defined by fulfilled ICD-10 criteria for diseases F32.1-3, F33.1-3. Age between 18 and 75 years (both included). Admission not required at the time of inclusion. Secure contraception 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Fulfilled ICD-10 criteria for diseases F20-29, F30-31 or change of principal diagnosis during the study. Sarcoidosis. Tuberculosis. 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 5 nmoles per liter or above 100 nmoles per liter. Pregnancy or wanted pregnancy. Nursing women. Already participated in the trial. Daily intake of vitamin D3 above 10 mikrograms. Allergy towards tablet contents. Not received electroconvulsive treatment within the last 6 months. No informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether or not outpatients with depression (as defined by ICD-10 criteria for F32.1-3, F33.1-3) and a plasma concentration of 25-hydroxy-vitamin D3 below 100 nmoles per liter can benefit from vitamin D supplementation regarding their depression. ;Secondary Objective: To investigate whether or not there is a correlation between the severity of symptoms in outpatients with depression (as defined by ICD-10 criteria for F32.1-3, F33.1-3) and the plasma concentration of 25-hydroxy-vitamin D3. ;Primary end point(s): Major Depression Inventory (MDI) score. Hamilton-6 score. World Health Organization Five Well-Being Index (WHO-5) score. Plasma concentration of 25-hydroxy-vitamin D3.	—

Measure

Time frame

Main Objective: To investigate whether or not outpatients with depression (as defined by ICD-10 criteria for F32.1-3, F33.1-3) and a plasma concentration of 25-hydroxy-vitamin D3 below 100 nmoles per liter can benefit from vitamin D supplementation regarding their depression. ;Secondary Objective: To investigate whether or not there is a correlation between the severity of symptoms in outpatients with depression (as defined by ICD-10 criteria for F32.1-3, F33.1-3) and the plasma concentration of 25-hydroxy-vitamin D3. ;Primary end point(s): Major Depression Inventory (MDI) score. Hamilton-6 score. World Health Organization Five Well-Being Index (WHO-5) score. Plasma concentration of 25-hydroxy-vitamin D3.

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026