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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 (DonneDVit)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Enrolling

Conditions

Transient Hypercalciuria

Treatments

Drug: Cholecalciferol sequential dose
Drug: Cholecalciferol daily dose

Study type

Interventional

Funder types

Other

Identifiers

NCT02975492
RECHMPL15_0500
UF 9676 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

280 estimated patients

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

280 participants in 2 patient groups

Cholecalciferol sequential dose
Experimental group
Description:
cholecalciferol : 100 000 Unit International (UI), sequential dose (2 mL)
Treatment:
Drug: Cholecalciferol sequential dose
Cholecalciferol daily dose
Experimental group
Description:
cholecalciferol : 1000 UI, daily dose during 28 days (0.1 ml by day)
Treatment:
Drug: Cholecalciferol daily dose

Trial contacts and locations

2

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Central trial contact

Denis MORIN, MD

Data sourced from clinicaltrials.gov

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