The effect of vitamin D supplementation on vitaminD levels in patients with severe mental illness - a prospective trial

The effect of vitamin D supplementation on vitaminD levels in patients with severe mental illness - a prospective trial - VIDEPA-study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42464

Enrollment

Registered

2015-07-28

Start date

2015-10-12

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Vitamin D-deficiency / lack of vitamin D

Interventions

Daily intake of 800 IU cholecalciferol in all patients with inadequate vitamin D levels for 3 months. The dose will be increased to 1600 IU daily for another 3 months if the level is still inadequat

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients treated by a health care provider from Yulius - Informed consent - Severe mental illness (SMI)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is an adequate level of vitamin D in at least 80% of the study population after treatment with 800 IU or 1600 IU of vitamin D for 3 months.	—

Secondary

Measure	Time frame
The main secondary endpoints are: cost-effectiveness of the treatment of all patients with SMI with respect to the treatment of only those patients with a vitamin D deficiency; average increase of the vitamin D levels per100 IU cholecalciferol and the influence of the psychiatric disease on the required amount of vitamin D.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)