| Trial ID: | L1290 |
| Source ID: | NCT02238418
|
| Associated Drug: |
Cholecalciferol Vial (100 000 Ui)
|
| Title: |
Efficacy of Usual Vitamin D Supplementation and Its Impact on Children and Adolescents Calciuria.
|
| Acronym: |
VITATOL
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease|Renal Transplantation|Nephrotic Syndrome
|
| Interventions: |
DRUG: Cholecalciferol vial (100 000 UI)
|
| Outcome Measures: |
Primary: Efficacy of usual vitamin D supplementation, The 25 OH vitamin D serum concentration will be measured at inclusion (before treatment intake) and 2 months after supplementation. No extra blood intake is programmed since this parameter is always measured in this population. The main evaluation criterion is defined as a 25 OH vitamin D serum concentration over 75 nmol/l at month 2. This defines the success of supplementation. The failure is defined as a 25 OH vitamin D serum concentration under 75 nmol/l at month 2., Day 60 | Secondary: Kinetics of calciuria after a 100 000 IU vial of cholecalciferol, Calciuria (absolute and normalized with the calculation of the ratio urinary calcium/creatinine) will be measured on the first morning urine at those time points after each vial intake. Measurements will be made in the unique local laboratory chosen by each patient. Thus the lab will be different between patients but must remain the same for each patient., Day 0, day 1, day 2, day 3, day 4, day 7 after treatment intake.
|
| Sponsor/Collaborators: |
Sponsor: Hospices Civils de Lyon
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
43
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
|
| Start Date: |
2014-09
|
| Completion Date: |
2017-10
|
| Results First Posted: |
|
| Last Update Posted: |
2018-07-18
|
| Locations: |
Centre de Référence des Maladies Rénales Rares - Hospices Civils de Lyon - Service de Néphrologie et Rhumatologie Pédiatriques - Hôpital Femme Mère Enfant, Bron, 69500, France
|
| URL: |
https://clinicaltrials.gov/show/NCT02238418
|
