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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

Evaluation de l'Impact d'un Mode de supplémentation en Vitamine D (Dose séquentielle vs Dose Quotidienne) Sur l'Incidence de l'Hypercalciurie Chez Des Sujets Des départements du Gard et de l'Hérault agés de 2 à 18 Ans. Etude contrôlée randomisée en 2 Groupes parallèles

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02975492
Acronym
DonneDVit
Enrollment
280
Registered
2016-11-29
Start date
2017-12-14
Completion date
2024-12-31
Last updated
2023-04-10

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

Conditions

Transient Hypercalciuria

Brief summary

Recommendations for vitamin D supplementation for subjets between 2 and 18 years offer strong sequential doses of vitamin D: 2 times 100 000 units in spaced winter period of 3 months. Data from the literature show a further increase in the incidence of oxalo-calcium stones in children and adolescents associated with hypercalciuria with training Randall plates, essential step lithogenesis calcium oxalate. Knowing the links between vitamin D and urinary calcium excretion, these data lead to the question of increased sensitivity in some children with vitamin D, sensitivity could explain these situations with hypercalciuria increase the gallstone risk. This increased sensitivity to vitamin D may unmask particularly if inputs of high doses of vitamin responsible then a transient hypercalciuria with development of microcrystals.

Interventions

DRUGCholecalciferol sequential dose

sequential dose administration of the treatment

DRUGCholecalciferol daily dose

daily dose administration of the treatment

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Children aged 2 to 17 years included * Obtaining informed consent of the parents signed * Participants aged 18 years included

Design outcomes

Primary

MeasureTime frame
Changes from calcium level in urines at day 7, day 14 and day 28day 7, day 14 and day 28

Countries

France

Contacts

Primary ContactDenis MORIN, MD
d-morin@chu-montpellier.fr0467336607

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026