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

NCT02238418 | Completed Phase 4

• 2 other identifiers: 2013-8122013-002710-13
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Renal Transplantation; Nephrotic Syndrome

Keywords

Vitamin D, Calciuria, Paediatrics, Nephrology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Kinetics of calciuria after a 100 000 IU vial of cholecalciferol

  Day 0, day 1, day 2, day 3, day 4, day 7 after treatment intake.

Study Arms (1)

Usual vitamin D supplementation

EXPERIMENTAL

Drug: Cholecalciferol vial (100 000 UI)

Interventions

Cholecalciferol vial (100 000 UI) DRUG

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

Usual vitamin D supplementation

Eligibility Criteria

• Age: 18 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age : between \[18 mo et 18 yo\[
• Patients seen in the paediatric nephrology service and having :
• Chronic kidney disease
• Renal transplant
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre de Référence des Maladies Rénales Rares - Hospices Civils de Lyon - Service de Néphrologie et Rhumatologie Pédiatriques - Hôpital Femme Mère Enfant

Bron, 69500, France

Location

Related Publications (1)

• Aurelle M, Basmaison O, Ranchin B, Kassai-Koupai B, Sellier-Leclerc AL, Bertholet-Thomas A, Bacchetta J. Intermittent cholecalciferol supplementation in children and teenagers followed in pediatric nephrology: data from a prospective single-center single-arm open trial. Eur J Pediatr. 2020 Apr;179(4):661-669. doi: 10.1007/s00431-019-03553-y. Epub 2019 Dec 24.

  PMID: 31873802 RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Nephrotic Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nephrosis

Study Officials

• Justine Bacchetta, MD

  HCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 12, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)