Chronic Kidney Disease Clinical Trial
Official title:
Vitamin D Supplementation in Children and Adolescents Seen in the Paediatric Nephrology Service: Study of the Efficacy of Service Usual Care (Cholecalciferol) and Its Impact on Calciuria.
Vitamin D is not seen anymore only as a phosphocalcic and bone hormone, but also as having an
effect on global health (anti-infective, anti-inflammatory, anti-tumour roles and
cardiovascular protection).
Until recently, vitamin D repletion was defined as the minimal concentration that enables the
prevention of rickets in children and osteomalacia in adults, i.e, approximately 8 ng/mL (20
nmol/L). However, most of the international experts agree to set minimal threshold of 25 OH
vitamin D serum concentration, higher than the one previously admitted, with a limit of 20
ng/mL (50 nmol/L) to define a vitamin D deficiency and a limit of 30 ng/mL (75 nmol/L) to
define vitamin D insufficiency.
Recommendations for Vit D supplementation in healthy children were updated in France in 2012.
The invariable supplementation of infants and toddlers is efficient since deficiency-related
rickets have almost disappeared; however there is very few information in ill children
populations.
Vit D supplementation tolerance is usually considered as good and over-dosage risks are low,
however these studies were conducted more than 30 years ago, and as far as we know, there is
no study about calcium urinary excretion kinetics after intake of a 100 000 IU vial of
cholecalciferol (Uvedose®). When 25 OH vitamin D serum concentrations exceeds 200 ng/mL,
which is very rare in daily practice, toxic effects of Vit D may theoretically be observed,
particularly hypercalcemia and hypercalciuria.
Vitamin D deficit is very common in children with chronic kidney disease (CKD) with a 50 to
92% prevalence depending on the studies; it it is a risk factor for secondary
hyperparathyroidism.
Although international guidelines regarding the care of CKD children recommend 25 OH vitamin
D serum concentrations over 75 nmol/L, there are no practical recommendations in terms of
dose and frequency of native Vit D treatment.
Therefore, the objectives of the present study has are the following:
- to validate prospectively the efficacy of our service usual care for Vit D
supplementation of children and adolescents seen in the paediatric nephrology
department.
- and to study the effect of Vit D supplementation (100 000 IU vial of cholecalciferol) on
calciuria in these patients.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
| Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
| Terminated |
NCT04043026 -
The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
|
||
| Completed |
NCT05318014 -
Low-protein Formula Supplements in Chronic Kidney Disease
|
N/A | |
| Active, not recruiting |
NCT06071065 -
Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients
|
N/A | |
| Completed |
NCT02878317 -
Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
|
||
| Not yet recruiting |
NCT06039254 -
Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function
|
Phase 1 | |
| Recruiting |
NCT03160326 -
The QUALITY Vets Project: Muscle Quality and Kidney Disease
|
||
| Completed |
NCT02875886 -
DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease
|
Phase 4 | |
| Completed |
NCT02896309 -
The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity
|
N/A | |
| Withdrawn |
NCT02885545 -
The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial
|
Phase 4 | |
| Completed |
NCT02756520 -
Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
|
||
| Completed |
NCT02836574 -
A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease
|
Phase 2 | |
| Completed |
NCT02888171 -
Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
|
N/A | |
| Active, not recruiting |
NCT02483039 -
Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization
|
N/A | |
| Terminated |
NCT02543177 -
Optimised Procedure in Patients With NSTEMI and CKD
|
N/A | |
| Completed |
NCT02992548 -
Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease
|
Phase 4 | |
| Completed |
NCT02369549 -
Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease
|
Phase 3 | |
| Recruiting |
NCT02205944 -
Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes
|
N/A | |
| Active, not recruiting |
NCT02231138 -
Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease
|
Phase 4 |