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Efficacy of Usual Vitamin D Supplementation and Its Impact on Children and Adolescents Calciuria. (VITATOL)

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ClinicalTrials.gov Identifier: NCT02238418
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Renal Transplantation Nephrotic Syndrome Drug: Cholecalciferol vial (100 000 UI) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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.
Actual Study Start Date : September 2014
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

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Arm Intervention/treatment
Experimental: Usual vitamin D supplementation Drug: Cholecalciferol vial (100 000 UI)

VISIT 1:

Patient > 60 kg and initial 25OHD serum concentration < 25nmol/L : prescription of 4 vials to be taken every 2 weeks between 25 and 50 nmol/L: prescription of 3 vials to be taken every 2 weeks between 50 and 75 nmol/L: prescription of 2 vials to be taken every 2 weeks Patient between 20 and 60 kg and initial 25OHD serum concentration < 25nmol/L: prescription of 2 vials to be taken every month between 25 and 50 nmol/L: prescription of 2 vials to be taken every 6 weeks between 50 and 75 nmol/L: prescription of 1 single vial Patient < 20 kg and initial 25OHD serum concentration < 75 nmol/L: prescription of 1 single vial

A local lab will performed urinary dosage of calciuria and creatininuria:

  • at days 0, 1, 2, 3, 4 and 7 after the first intake of a 25OHD vial
  • at days 0, 2 and 4 after other intakes (when applicable)

VISIT 2:

25OHD serum concentration will then be dosed at month 2 after visit 1





Primary Outcome Measures :
  1. Efficacy of usual vitamin D supplementation [ Time Frame: Day 60 ]
    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.


Secondary Outcome Measures :
  1. Kinetics of calciuria after a 100 000 IU vial of cholecalciferol [ Time Frame: Day 0, day 1, day 2, day 3, day 4, day 7 after treatment intake. ]
    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.



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Ages Eligible for Study:   18 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age : between [18 mo et 18 yo[
  • Patients seen in the paediatric nephrology service and having :

    • Chronic kidney disease
    • Renal transplant
    • Stable nephrotic syndrome (i.e., normal protidemia at inclusion)
  • Initial 25 OH vitamin D concentration < 75nmol/l
  • Patient agree to participate (if old enough to give his agreement) and written informed consent signed by parents
  • Patients affiliated within the French universal healthcare system

Exclusion Criteria:

- Contraindication to 100 000 IU Uvedose® treatment (according to the Summary of Product Characteristics: known hypersensitivity to vitamin D or hypercalcemia, hypercalciuria or nephrolithiasis).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238418


Locations
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France
Centre de Référence des Maladies Rénales Rares - Hospices Civils de Lyon - Service de Néphrologie et Rhumatologie Pédiatriques - Hôpital Femme Mère Enfant
Bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Justine Bacchetta, MD HCL

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02238418     History of Changes
Other Study ID Numbers: 2013-812
2013-002710-13 ( EudraCT Number )
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospices Civils de Lyon:
Vitamin D, Calciuria, Paediatrics, Nephrology
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Nephrotic Syndrome
Nephrosis
Urologic Diseases
Renal Insufficiency
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents