Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
48
Countries
1
Sites
1
Patients with low Vitamin D plasma level
Key facts
- Sponsor
- Centro Ricerche Cliniche Di Verona S.r.l.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 9 Dec 2025 → ongoing
- Decision date (initial)
- 2024-12-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with low Vitamin D plasma level
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centro Ricerche Cliniche Di Verona S.r.l.
- Sponsor organisation
- Centro Ricerche Cliniche Di Verona S.r.l.
- Address
- Piazzale Ludovico Antonio Scuro 10
- City
- Verona
- Postcode
- 37134
- Country
- Italy
Scientific contact point
- Organisation
- Centro Ricerche Cliniche Di Verona S.r.l.
- Contact name
- Stefano Milleri
Public contact point
- Organisation
- Centro Ricerche Cliniche Di Verona S.r.l.
- Contact name
- Stefano Milleri
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 48 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2025-12-09 | 2025-12-15 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-14 | Italy | Acceptable with conditions 2024-12-02
|
2024-12-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-18 | Italy | Acceptable 2025-02-19
|
2025-02-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-30 | Italy | Acceptable | 2025-08-26 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-09 | Italy | Acceptable 2025-11-20
|
2025-11-26 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-22 | Italy | Acceptable 2025-11-20
|
2025-12-22 |