Vitamin D DeficiencyEVADDREPNCT04694976
Vitamin D Status in Children With Sickle Cell Disease Living in Lyon, France
An observational study of Vitamin D Deficiency and Sickle Cell Disease, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Vitamin D Deficiency, Sickle Cell Disease
- What is being tested?
- 25-OH Vitamin D measure
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2021to 3 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- History of hematologic grafting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Vitamin D Deficiency Distribution in Children With Sickle Cell Disease Followed 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.
- Conditions
- Vitamin D Deficiency, Sickle Cell Disease
- Being tested
- 25-OH Vitamin D measure
- Keywords
- Vitamin D deficiency prevalence rate, Vitamin D level, Children with sickle cell disease
- Medical subject headings
- Vitamin D Deficiency, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25-OH Vitamin D measureBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: 25-OH Vitamin D measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start4 Feb 2021
- Primary completion3 Feb 2022
- Study completion3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie LAUNAY, MD, Principal investigator, Urgences pédiatriques de l'Hôpital Femme Mère Enfant - Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694976
- Sponsor's protocol ID
- 69HCL20_0885
- Other IDs
- ID-RCB
- Acronym
- EVADDREP
- Status last verified
- Jul 2023
- First submitted
- 31 Dec 2020
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vitamin D Deficiency Distribution in Children With Sickle Cell Disease Followed in Lyon, France
- ClinicalTrials.gov ID
- NCT04694976
- Acronym / sponsor ID
- EVADDREP / 69HCL20_0885
- Conditions
- Vitamin D Deficiency, Sickle Cell Disease
- Keywords
- Vitamin D deficiency prevalence rate, Vitamin D level, Children with sickle cell disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sickle cell disease children from Lyon, France | – | Biological: 25-OH Vitamin D measureSickle 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- History of hematologic grafting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 25-OH Vitamin D measureAs 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. | Biological | Sickle cell disease children from Lyon, France |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie LAUNAY, MD principal investigator
Urgences pédiatriques de l'Hôpital Femme Mère Enfant - Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Sickle Cell Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of 25-OH Vitamin D level (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.