Authorised Therapeutic use (Phase IV) Transient hypercalciuria

DonneDvit : Assessing the Impact of a Mode of Vitamin D Supplementation on the Incidence of Hypercalciuria in Subjets Aged From 2 to 18 Years.

EU CTIS ID: 2024-518219-20-00

What this study is testing

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.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Children aged 2 to 18 years included
  • Obtaining informed consent of the parents signed/the adult subject
  • Subjects covered by a social security scheme

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • Children aged 2 to 18 years included
  • Obtaining informed consent of the parents signed/the adult subject
  • Subjects covered by a social security scheme
What rules you out
  • 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.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.