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

NCT04694976 | Completed

• 2 other identifiers: 69HCL20_0885ID-RCB
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vitamin D Deficiency; Sickle Cell Disease

Keywords

Vitamin D deficiency prevalence rate; Vitamin D level; Children with sickle cell disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

25-OH Vitamin D measure BIOLOGICAL

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.

Sickle cell disease children from Lyon, France

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• History of hematologic grafting

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Femme Mère enfant - Urgences pédiatriques

Bron, 69500, France

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Valérie LAUNAY, MD

  Urgences pédiatriques de l'Hôpital Femme Mère Enfant - Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: January 5, 2021
• Study Start: February 4, 2021
• Primary Completion: February 3, 2022
• Study Completion: February 3, 2022
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

FR (1)