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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)

Primary Purpose

Transient Hypercalciuria

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Cholecalciferol sequential dose

Cholecalciferol daily dose

About this trial

This is an interventional prevention trial for Transient Hypercalciuria

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Children aged 2 to 6 years included included
Obtaining informed consent of the parents signed

Sites / Locations

Pediatric departmentRecruiting
Pediatric departmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cholecalciferol sequential dose

Cholecalciferol daily dose

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02975492

First Posted

November 7, 2016

Last Updated

April 7, 2023

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT02975492

Brief Title

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

Acronym

DonneDVit

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 14, 2017 (Actual)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Transient Hypercalciuria

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cholecalciferol sequential dose

Arm Type

Experimental

Arm Description

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

Arm Title

Cholecalciferol daily dose

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cholecalciferol sequential dose

Other Intervention Name(s)

Vitamin D

Intervention Description

sequential dose administration of the treatment

Intervention Type

Drug

Intervention Name(s)

Cholecalciferol daily dose

Other Intervention Name(s)

Vitamin D

Intervention Description

daily dose administration of the treatment

Primary Outcome Measure Information:

Title

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

Time Frame

day 7, day 14 and day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Denis MORIN, MD

Phone

0467336607

d-morin@chu-montpellier.fr

Facility Information:

Facility Name

Pediatric department

City

Montpellier

ZIP/Postal Code

34295

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Denis MORIN, MD

Facility Name

Pediatric department

City

Nîmes

ZIP/Postal Code

30029

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tu-Anh TRAN, MD

Phone

04 66 68 32 84

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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