NCT06581900 Study of Vitamin B12 Metabolism in Children With Sickle Cell Disease Exposed to MEOPA
| NCT ID | NCT06581900 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CHU de Reims |
| Condition | Sickle Cells Patients |
| Study Type | OBSERVATIONAL |
| Enrollment | 29 participants |
| Start Date | 2024-11-27 |
| Primary Completion | 2026-11-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 29 participants in total. It began in 2024-11-27 with a primary completion date of 2026-11-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) The sickle cells anemia is a monogenic disease linked to the presence of Hemoglobin S due to a mutation in the Hemoglobin Beta chain. The lack of circulating oxygen induces a polymerization of the Hemoglobin S which change the red cell conformation into sickle. Those cells interact and causes vaso-occlusive crisis (CVO). The MEOPA is a medical gas used as an antalgic and a sedative especially in sickle cells disease patients. The nitrous oxide, oxide the cobalt ion in the vitamin B12 which inactivate it irreversibly creating a functional deficiency. During the metabolism of vitamin B12, homocysteine is transformed in methionine which is used in to form the myelin sheath and helped in producing DNA. Numerous studies already shown that the longer the exposition to MEOPA is the greater the functional deficiency of vitamin B12 occur. A few studies shown a symptomatic deficiency of vitamin B12 due to the exposition of MEOPA in sickle cells patient but there is no explanation on the necessary amount of exposure or if some patients are more at risk. When there is a deficiency of vitamin B12 the symptoms can go from a simple orthostatic hypotension to a combined spinal sclerosis. The participation to the study will be proposed to every patient hospitalized for a CVO in the follow up of the emergency room visit or directly in pediatric reanimation. During a usual blood test, a small amount of blood (4mL) will be collected in addition to dose the Vitamin B12, the vitamin B9, the homocysteine, and the methionine. A small amount of urine will also be collected to dose the methylmalonic acid, all those elements are a part of the metabolism of B12 vitamin. The same sample will be taken on the day of departure of the hospital. During the hospitalization the pain management, a daily neurological exam, and the exposition to the MEOPA will be assessed meticulously. An appointment will take place at 7 days and at one month after the hospital departure to evaluate the possible neurological defect. Each patient can only be included once.
Eligibility Criteria
Inclusion Criteria: * Sickle cells patient * Age between 2 and 18 years old * Being affiliated with social security Exclusion Criteria: * Having a neurological defect prior to the study * Being against the collection of blood or data
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06581900 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 18 Years, studying Sickle Cells Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06581900 currently recruiting?
Yes, NCT06581900 is actively recruiting participants. Contact the research team at cpluchart@chu-reims.fr for enrollment information.
Where is the NCT06581900 trial being conducted?
This trial is being conducted at Reims, France.
Who is sponsoring the NCT06581900 clinical trial?
NCT06581900 is sponsored by CHU de Reims. The trial plans to enroll 29 participants.
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