Cholecalciferol (colecalciferol) for Transient hypercalciuria

Inclusion criteria

• {"criterion_text":"- Children aged 2 to 18 years included\n- Obtaining informed consent of the parents signed/the adult subject\n- Subjects covered by a social security scheme"}

Exclusion criteria

• {"criterion_text":"- 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 (Cholécalciférol), 200,000 U, Stérogyl 15A or 15H (Ergocalciferol) within the three months prior to inclusion in the study\n- Subject treated with Uvesterol 5000 IU\n- 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.\n- Subject receiving a treatment that induces hypercalciuria (systemic corticosteroids, diuretics)\n- Subject receiving calcium supplementation justified by a medical need\n- Subject with prolonged immobilization\n- Subject participating in another interventional research program."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured by calcium/creatinine ratio in mmol/mmol on the first morning urine sample on at least one of the measurements at day 7, day 14 and day 28; threshold is the age-specific lithogenic threshold."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Crystalluria analysis on the first morning urine sample at J7, J14 and J28; analysis to be performed in the biochemistry laboratory of CHU de Montpellier."}
• {"endpoint_text":"- Evaluation of tolerance: systematic collection of expected and unexpected adverse events.","definition_or_measurement_approach":"Systematic collection/recording of adverse events at each visit (expected and unexpected adverse events)."}

Methods

• Recruitment brochure (document: 'Recruitment brochure_Clean_FP_DonneDvit') — materials prepared for participants/parents (France).
• Recruitment poster (document: 'Recruitment poster_CLEAN_FP_DonneDvit') — poster materials for participants/parents (France).
• Recruitment arrangements documents present ('Part-II_MissingDocuments_Transition_DONNEDVIT' and 'Recruitment Arrangements _DONNEDVIT_FR') indicating organised site-based recruitment at participating hospitals in France (CHU Montpellier, CHU Nimes).

France

Earliest CTIS Part Ii Submission Date

08-11-2024

Latest Decision Or Authorization Date

28-02-2025

Processing Time Days

112

Number Of Sites

2

Number Of Participants

280

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Montpellier

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"DGOS","duties_or_roles":"Source of monetary support","organisation_type":""}