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

Sickle Cell Disease Clinical Trial

— EVADDREP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04694976
• Other study ID #: 69HCL20_0885
• Secondary ID: ID-RCB
• Status: Completed
• Start date: February 4, 2021
• Est. completion date: February 3, 2022

Study information

• Verified date: July 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: February 3, 2022
• Est. primary completion date: February 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease
• Vitamin D Deficiency

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Femme Mère enfant - Urgences pédiatriques	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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