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

Completed

• Conditions: Vitamin D Deficiency; Sickle Cell Disease
• Interventions: Biological: 25-OH Vitamin D measure

• Registration Number: NCT04694976
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-31
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-05
• Study Start: 2021-02-04
• Primary Completion: 2022-02-03
• Study Completion: 2022-02-03
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

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Exclusion Criteria

• History of hematologic grafting

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sickle cell disease children from Lyon, France	25-OH Vitamin D measure	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.

Primary Outcome Measures

Name	Time	Method
Determination of 25-OH Vitamin D level	Day 1	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)

Trial Locations

Locations (1)

Hôpital Femme Mère enfant - Urgences pédiatriques; 🇫🇷 Bron, France