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EFFECTIVENESS OF SUPPLEMENTATION WITH VITAMIN D IN PATIENTS WITH DEPRESSIVE DISORDER OR BIPOLAR DISORDER: A RANDOMIZED CONTROLLED CLINICAL TRIAL

Status
Not yet recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520778-20-00
Acronym
VIT_D_2018
Enrollment
150
Registered
2025-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-10

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

Conditions

Depressive disorder, Bipolar disorder

Brief summary

Change in Montgomery-Asberg Depression Rating Scale - MADRS at 12 weeks of treatment, Time to remission of depressive disorder (Montgomery-Asberg Depression Rating Scale -MADRS≤ 10)

Detailed description

Changes in Montgomery-Asberg Depression Rating Scale (MADRS) score at 24 weeks, Changes in 25OH vitamin D levels at 12 and 24 weeks

Interventions

DRUGOlive oil
DRUGrefined vehicle 2
DRUG5 ml (quality standard Ph. Eur. current edition monograph 1456)
DRUGDIBASE 50.000 U.I./2
DRUG5 ml soluzione orale in contenitore monodose

Sponsors

Azienda Ospedaliera Universitaria Senese
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in Montgomery-Asberg Depression Rating Scale - MADRS at 12 weeks of treatment, Time to remission of depressive disorder (Montgomery-Asberg Depression Rating Scale -MADRS≤ 10)—

Secondary

MeasureTime frame
Changes in Montgomery-Asberg Depression Rating Scale (MADRS) score at 24 weeks, Changes in 25OH vitamin D levels at 12 and 24 weeks—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026