DonneDvit : Assessing the Impact of a Mode of Vitamin D Supplementation on the Incidence of Hypercalciuria in Subjets Aged From 2 to 18 Years.
- Conditions
- Transient hypercalciuria
- Registration Number
- 2024-518219-20-00
- Lead Sponsor
- Centre Hospitalier Universitaire De Montpellier
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 280
Children aged 2 to 18 years included
Obtaining informed consent of the parents signed/the adult subject
Subjects covered by a social security scheme
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. 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 Outcome Measures
Name Time Method 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. 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. Evaluation of tolerance: systematic collection of expected and unexpected adverse events.
Trial Locations
- Locations (2)
Centre Hospitalier Universitaire De Nimes
🇫🇷Nimes Cedex 9, France
Centre Hospitalier Universitaire De Montpellier
🇫🇷Montpellier Cedex 5, France
Centre Hospitalier Universitaire De Nimes🇫🇷Nimes Cedex 9, FranceTu-Anh TRANSite contact0466683284tu.anh.tran@chu-nimes.fr