Vitamin D supplements to prevent depression and poor physical function in persons over 60 years
Phase 1
- Conditions
- depressive symptoms, poor physical functioning.Therapeutic area: Not possible to specify
- Registration Number
- EUCTR2012-005332-29-NL
- Lead Sponsor
- VU University Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- age 60-80 years
- mild depressive symptoms
- at least one functional limitation
- serum 25(OH)D levels between 15 and 50 nmol/l (winter) or 15 and 70 nmol/l (summer)
- ability to comply with the study
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 115
Exclusion Criteria
- full-blown depressive disorder
- use of antidepressants
- vitamin D (more than 400 IU/day) or calcium (more than 1000 mg/day) supplementation
- major life-threatening illness
- living in an aged-people's home or nursing home
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