The role of vitamin D supplementation on symptoms in patients treated for depression. A double-blind randomized trial.
- Conditions
- Depression as defined by fulfilled ICD-10 criteria for diseases F32.1-3, F33.1-3.MedDRA version: 14.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders
- Registration Number
- EUCTR2010-023531-42-DK
- Lead Sponsor
- Psykiatrien i Region Syddanmark
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method