Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
280
Countries
1
Sites
2
Transient hypercalciuria
To evaluate the impact of the mode of vitamin D supplementation (high sequential dose or daily intake) on the incidence of hypercalciuria (urinary calcium/creatinine ratio) measured on day 7, day 14, and day 28 in Mediterranean subjects aged 2 to 18 years inclusive.
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Montpellier
- Participant type
- Pediatric, Healthy volunteers
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]
- Decision date (initial)
- 2024-11-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- DGOS
External identifiers
- EU CT number
- 2024-518219-20-00
- EudraCT number
- 2016-001807-22
- ClinicalTrials.gov
- NCT02975492
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response
To evaluate the impact of the mode of vitamin D supplementation (high sequential dose or daily intake) on the incidence of hypercalciuria (urinary calcium/creatinine ratio) measured on day 7, day 14, and day 28 in Mediterranean subjects aged 2 to 18 years inclusive.
Secondary objectives 2
- To study the impact of vitamin D supplementation (cholecalciferol) on the occurrence of calcium oxalate microcrystals in Mediterranean subjects aged 2 to 18 years inclusive.
- To evaluate the tolerance to vitamin D treatment: Uvedose (cholecalciferol) 100,000 units once or Adrigyl (cholecalciferol) 1,000 units per day for 28 days (systematic collection of adverse events).
Conditions and MedDRA coding
Transient hypercalciuria
Study design 4 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Period J0 Both arms : Urine and blood tests / Initiation of treatment: UVEDOSE group (high sequential dose) : taking the single dose of vitamin D and ADRIGYL group (daily intake) : taking the first dose
|
Randomised Controlled | None | ||
| 2 | Period J7 Group ADRIGYL : Continuation of treatment / Both arms : Urine test
|
Not Applicable | None | ||
| 3 | Period J14 Group ADRIGYL : Continuation of treatment / Both arms : Urine test
|
Not Applicable | None | ||
| 4 | Period J28 Group ADRIGYL : End of treatment / Both arms : Urine test
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Children aged 2 to 18 years included
- Obtaining informed consent of the parents signed/the adult subject
- Subjects covered by a social security scheme
Exclusion criteria 7
- Subject who received a dose of vitamin D (80,000 or 100,000 units or more): Uvedose (Cholecalciferol) 5,000, 100,000 U, Zyma D 80,000 U (Cholecalciferol), 200,000 U, Stérogyl 15A or 15H (Ergocalciferol) within the three months prior to inclusion in the study
- Subject treated with Uvesterol 5000 IU
- Subject with a known condition that may affect calcium-phosphate metabolism: 1/ renal failure, chronic kidney disease, 2/endocrine disorder (thyroid, parathyroid, hypersensitivity to vitamin D, etc.), 3/ chronic liver and/or digestive disease, 4/congenital bone disease.
- Subject receiving a treatment that induces hypercalciuria (systemic corticosteroids, diuretics)
- Subject receiving calcium supplementation justified by a medical need
- Subject with prolonged immobilization
- Subject participating in another interventional research program.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Occurrence of hypercalciuria beyond the lithogenic threshold for age. This will be assessed by measuring the calcium/creatinine ratio in mmol/mmol in the first morning urine sample collected during at least one of the three measurements taken on day 7, day 14, and day 28.
Secondary endpoints 2
- Detection of calcium oxalate microcrystals in the first morning urine sample during at least one of the three crystalluria analyses conducted on day 7, day 14, and day 28.
- Evaluation of tolerance: systematic collection of expected and unexpected adverse events.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
ADRIGYL 10 000 UI/ml, solution buvable en gouttes
PRD474710 · Product
- Active substance
- Colecalciferol
- Substance synonyms
- CHOLECALCIFEROL, VITAMIN D3, COLECALCIPHEROL
- Pharmaceutical form
- ORAL DROPS, SOLUTION
- Route of administration
- ORAL
- Max daily dose
- 1000 IU international unit(s)
- Max total dose
- 28000 IU international unit(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- A11CC05 — COLECALCIFEROL
- Marketing authorisation
- 3400934423079
- MA holder
- LABORATOIRES CRINEX
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
UVEDOSE 100 000 UI, solution buvable en ampoule
PRD474711 · Product
- Active substance
- Colecalciferol
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL
- Max daily dose
- 100000 IU international unit(s)
- Max total dose
- 100000 IU international unit(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- A11CC05 — COLECALCIFEROL
- Marketing authorisation
- NL15608-3400933222185
- MA holder
- LABORATOIRES CRINEX
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Montpellier
- Sponsor organisation
- Centre Hospitalier Universitaire De Montpellier
- Address
- 80 Avenue Augustin Fliche
- City
- Montpellier Cedex 5
- Postcode
- 34295
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Montpellier
- Contact name
- Pr MORIN Denis
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Montpellier
- Contact name
- ROSSIGNOL Ludivine
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 280 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Montpellier
Néphrologie et Endocrinologie pédiatrique, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Nimes
Pediatrie, Place Du Professeur Robert Debre, 30029, Nimes Cedex 9
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 21 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 2024-518219-20-00_Protocol_CLEAN_ FP_DONNEDVIT | 11 |
| Protocol (for publication) | 2024-518219-20-00_Protocol_CLEAN_FP | 11 |
| Protocol (for publication) | 2024-518219-20-00_PROTOCOLE_DONNEDVIT | 10 |
| Recruitment arrangements (for publication) | 2024-518219-20-00_Part-II_MissingDocuments_Transition_DONNEDVIT | 1 |
| Recruitment arrangements (for publication) | 2024-518219-20-00_Recruitment Arrangements _DONNEDVIT_FR | 1 |
| Subject information and informed consent form (for publication) | 2024-518219-20-00_ Recruitment brochure_Clean_FP_DonneDvit | 6 |
| Subject information and informed consent form (for publication) | 2024-518219-20-00_ Subject information adult _Clean_FP_DonneDvit | 3 |
| Subject information and informed consent form (for publication) | 2024-518219-20-00_ Subject information adult _DONNEDVIT_FP | 2 |
| Subject information and informed consent form (for publication) | 2024-518219-20-00_ Subject information parents_Clean_FP_DonneDvit | 10 |
| Subject information and informed consent form (for publication) | 2024-518219-20-00_Genetic consent form Adults _DONNEDVIT_FP | 2 |
| Subject information and informed consent form (for publication) | 2024-518219-20-00_Genetic consent form Parents _DONNEDVIT_FP | 6 |
| Subject information and informed consent form (for publication) | 2024-518219-20-00_Informed consent form adult _DONNEDVIT_FP | 2 |
| Subject information and informed consent form (for publication) | 2024-518219-20-00_Informed consent form parent _DONNEDVIT_FP | 7 |
| Subject information and informed consent form (for publication) | 2024-518219-20-00_Recruitment poster_CLEAN_FP_DonneDvit | 3 |
| Subject information and informed consent form (for publication) | 2024-518219-20-00_Subject information Children 13-17 years _DONNEDVIT_FP | 1 |
| Subject information and informed consent form (for publication) | 2024-518219-20-00_Subject information Children 2-6 years _DONNEDVIT_FP | 3 |
| Subject information and informed consent form (for publication) | 2024-518219-20-00_Subject information Children 7-12 years _DONNEDVIT_FP | 1 |
| Subject information and informed consent form (for publication) | 2024-518219-20-00_Subject information parent _DONNEDVIT_FP | 9 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-518219-20-00_SmPC UVEDOSE_ DONNEDVIT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-518219-20-00_SmPC_ ADRIGYL_ DONNEDVIT | 1 |
| Synopsis of the protocol (for publication) | 2024-518219-20-00_Synopsis_DONNEDVIT | 6 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-10 | France | Acceptable 2024-10-12
|
2024-11-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-08 | France | Acceptable 2025-01-31
|
2025-02-28 |