Vitamin D Status in Children With Sickle Cell Disease Living 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.

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Key information

Conditions

Vitamin D Deficiency Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Avitaminosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deficiency Diseases Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Sickle Cell Disease

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Femme Mère enfant - Urgences pédiatriques

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: EVADDREP

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jan 5, 2021
Registry last updated: Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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