ClinicalTrials.gg
CompletedNCT02975492DonneDVitUpdated Nov 2, 2026

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

An interventional study of Cholecalciferol sequential dose and Cholecalciferol daily dose in Transient Hypercalciuria, sponsored by University Hospital, Montpellier. Completed at 2 sites in France. Open to participants aged 2 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Prevention

Updated Nov 2, 2026Now CompletedPrimary completion moved+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
2 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Transient Hypercalciuria

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03

In context

Hypercalciuria

33 studies on the registry are indexed under Hypercalciuria; 4 are open to participants now.

This study's enrollment of 280 is above the median of 40 across 25 interventional studies indexed under Hypercalciuria.

Browse Hypercalciuria studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 2, 2026. See what changed

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • Children aged 2 to 18 years included
  • Obtaining of the parents signed
  • Subjects covered by a social security scheme
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
280 participants (actual)

Study arms

  • Experimental
    Cholecalciferol sequential dose

    cholecalciferol : 100 000 Unit International (UI), sequential dose (2 mL)

    Drug: Cholecalciferol sequential dose

  • Experimental
    Cholecalciferol daily dose

    cholecalciferol : 1000 UI, daily dose during 28 days (0.1 ml by day)

    Drug: Cholecalciferol daily dose

Interventions

06

What researchers measure

Primary outcomes

  1. Changes from calcium level in urines at day 7, day 14 and day 28

    Time frame: day 7, day 14 and day 28

07

Study locations

2 sites
  • Pediatric department
    Montpellier, 34295, France
  • Pediatric department
    Nîmes, 30029, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Dec 2017 to primary completion in Jun 2026, 101 months.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 2, 2026: primary completion May 2024 → Jun 2026 and completion Dec 2024 → Jun 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2016
First posted
Nov 29, 2016
StartActual
Dec 14, 2017
Primary completionActual
Jun 1, 2026was May 2024
CompletionActual
Jun 1, 2026was Dec 2024
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Status unknown→Completed
changed Nov 2, 2026
Primary completion
May 2024→Jun 1, 2026 (actual)
Nov 2, 2026
Study completion
Dec 2024→Jun 1, 2026 (actual)
Nov 2, 2026
Eligibility
1 criterion edited, 1 added, 1 removed
What changed in the criteria
  • EditedChildren aged 2 to 1718 years included
  • RemovedParticipants aged 18 years included
  • AddedSubjects covered by a social security scheme
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Status unknown→Completed
    Primary completion May 2024→Jun 1, 2026 (now actual)
    Study completion Dec 2024→Jun 1, 2026 (now actual)
    Eligibility 1 criterion edited, 1 added, 1 removed
    What changed in the criteria
    • EditedChildren aged 2 to 1718 years included
    • RemovedParticipants aged 18 years included
    • AddedSubjects covered by a social security scheme
    + 4 other changes: verification date, contact details, site details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT02975492
Responsible party
Sponsor
First posted
Nov 29, 2016
Start date
Dec 14, 2017
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026
Last update
Nov 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Vitamin D

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