Vitamin D Status in Children With Sickle Cell Disease Living in Lyon, France (EVADDREP)

Evaluation of Vitamin D Deficiency Distribution in Children With Sickle Cell Disease Followed in Lyon, France

Vitamin D deficiency may be under-diagnosed in sickle cell disease French children. Therefore, the investigator need an epidemiologic study about the prevalence of vitamin D deficiency in this specific population. There are not specific guidelines neither testing nor treatment. The investigator propose to test vitamin D status in all children with sickle cell disease who are consulting their referring haematologist doctor or in the emergency ward.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Sickle Cell Disease
• Intervention / Treatment: Biological: 25-OH Vitamin D measure

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

• Study Contact: Name: Valérie LAUNAY, MD; Phone Number: +33 04 27 85 62 13; Email: valerie.launay@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69500
    • Hôpital Femme Mère enfant - Urgences pédiatriques

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will focus on minor patients (0-17 years) with sickle cell disease, currently monitored in the active queue of the Lyon sickle cell reference centre of IHOPe, consulting their referring physician or paediatric emergencies of HFME, and having a blood test independently of the study.

Description

Inclusion Criteria:

• Children: under 18 years old
• Sickle cell any genetic type homozygous or composite heterozygous
• To receive an assessment independently of the study, during a presentation to the emergency ward and/or a follow-up consultation by the hematologist
• no parental opposition signed by at least one parent/legal representative and no child opposition
• social security beneficiary

Exclusion Criteria:

• History of hematologic grafting

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sickle cell disease children from Lyon, France; Sickle cell disease children, followed in IHOPe (Institut d'Hématologie et d'Oncologie Pédiatrique) center, consulting their referring haematologist doctor or in emergency ward, with prescribed blood sample.	Biological: 25-OH Vitamin D measure; As a complement to the off-study prescription, the investigator are taking two 1 mL tubes of extra blood to measure vitamin D, calcium, phosphorus, parathyroid hormone (PTH) and creatinine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of 25-OH Vitamin D level	We classify vitamin D status as follows : Sufficiency > >75nmol/L (>30 ng/mL); Insufficiency 50-75 nmol/L (20-30 ng/mL); Deficiency 12-50nmol/L (5-20 ng/mL); Severe deficiency <12 nmol/L (<5 ng/mL)	Day 1

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Valérie LAUNAY, MD, Urgences pédiatriques de l'Hôpital Femme Mère Enfant - Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2021
• Primary Completion (Actual): February 3, 2022
• Study Completion (Actual): February 3, 2022

Study Registration Dates

• First Submitted: December 31, 2020
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Children with sickle cell disease; Vitamin D deficiency prevalence rate; Vitamin D level
• Additional Relevant MeSH Terms: Hematologic Diseases; Nutrition Disorders; Genetic Diseases, Inborn; Anemia; Avitaminosis; Deficiency Diseases; Malnutrition; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Vitamin D Deficiency; Anemia, Sickle Cell; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 69HCL20_0885; ID-RCB (Other Identifier: 2023-A01937-38)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No