- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02975492
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)
April 7, 2023 updated by: University Hospital, Montpellier
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
280
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Denis MORIN, MD
- Phone Number: 0467336607
- Email: d-morin@chu-montpellier.fr
Study Locations
-
-
-
Montpellier, France, 34295
- Recruiting
- Pediatric department
-
Contact:
- Denis MORIN, MD
-
Nîmes, France, 30029
- Recruiting
- Pediatric department
-
Contact:
- Tu-Anh TRAN, MD
- Phone Number: 04 66 68 32 84
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Children aged 2 to 17 years included
- Obtaining informed consent of the parents signed
- Participants aged 18 years included
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cholecalciferol sequential dose
cholecalciferol : 100 000 Unit International (UI), sequential dose (2 mL)
|
sequential dose administration of the treatment
Other Names:
|
Experimental: Cholecalciferol daily dose
cholecalciferol : 1000 UI, daily dose during 28 days (0.1 ml by day)
|
daily dose administration of the treatment
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes from calcium level in urines at day 7, day 14 and day 28
Time Frame: day 7, day 14 and day 28
|
day 7, day 14 and day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 14, 2017
Primary Completion (Anticipated)
May 1, 2024
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
November 7, 2016
First Submitted That Met QC Criteria
November 28, 2016
First Posted (Estimate)
November 29, 2016
Study Record Updates
Last Update Posted (Actual)
April 10, 2023
Last Update Submitted That Met QC Criteria
April 7, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL15_0500
- UF 9676 (Other Identifier: Montpellier University Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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