Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581900
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Study of Vitamin B12 Metabolism in Children with Sickle Cell Disease Exposed to MEOPA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study of Vitamin B12 Metabolism in Children with Sickle Cell Disease Exposed to MEOPA a Prospective Study At Reims University Hospital
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DREPAM
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None