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DonneDVit : Assessing the Impact of a Mode of Vitamin D Supplementation (Sequential Dose vs Daily Dose) on the Incidence of Hypercalciuria in Subjets Aged From 2 to 18 Years. Randomized controlled trial with 2 parallel groups.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518219-20-00
Acronym
15_0500
Enrollment
280
Registered
2024-11-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transient hypercalciuria

Brief summary

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.

Detailed description

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.

Interventions

Sponsors

Centre Hospitalier Universitaire De Montpellier
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026