The effect of vitamin D supplementation on vitaminD levels in patients with severe mental illness - a prospective trial
Phase 4
Completed
- Conditions
- Vitamin D-deficiency / lack of vitamin D1004763510037176
- Registration Number
- NL-OMON42464
- Lead Sponsor
- GGz-instelling Yulius
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 62
Inclusion Criteria
- Patients treated by a health care provider from Yulius
- Informed consent
- Severe mental illness (SMI)
Exclusion Criteria
- High-Risk patients for vitamin D-deficiency according to the guideline of the Dutch Health Council Contra-indication for vitamin D supplementation
- Use of vitamin D supplementation
- Legally incapable
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of this study is an adequate level of vitamin D in at<br /><br>least 80% of the study population after treatment with 800 IU or 1600 IU of<br /><br>vitamin D for 3 months.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The main secondary endpoints are: cost-effectiveness of the treatment of all<br /><br>patients with SMI with respect to the treatment of only those patients with a<br /><br>vitamin D deficiency; average increase of the vitamin D levels per100 IU<br /><br>cholecalciferol and the influence of the psychiatric disease on the required<br /><br>amount of vitamin D.</p><br>