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

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ClinicalTrials.gov Identifier: NCT04694976
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : February 11, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Vitamin D Deficiency Sickle Cell Disease Biological: 25-OH Vitamin D measure

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Study Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of Vitamin D Deficiency Distribution in Children With Sickle Cell Disease Followed in Lyon, France
Actual Study Start Date : February 4, 2021
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2023


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.




Primary Outcome Measures :
  1. Determination of 25-OH Vitamin D level [ Time Frame: 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)



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04694976


Contacts
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Contact: Valérie LAUNAY, MD 04 27 85 62 13 ext +33 valerie.launay@chu-lyon.fr

Locations
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France
Hôpital Femme Mère enfant - Urgences pédiatriques Recruiting
Bron, France, 69500
Contact: Valérie LAUNAY, MD    04 27 85 62 13 ext +33    valerie.launay@chu-lyon.fr   
Principal Investigator: Valérie LAUNAY, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Valérie LAUNAY, MD Urgences pédiatriques de l'Hôpital Femme Mère Enfant - Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04694976    
Other Study ID Numbers: 69HCL20_0885
ID-RCB ( Other Identifier: 2020-A02709-30 )
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Vitamin D deficiency prevalence rate
Vitamin D level
Children with sickle cell disease
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Vitamin D Deficiency
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents