Study of Vitamin B12 Metabolism in Children With Sickle Cell Disease Exposed to MEOPA (DREPAM)

Study of Vitamin B12 Metabolism in Children With Sickle Cell Disease Exposed to MEOPA , a Prospective Study at Reims University Hospital

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.

Study Overview

• Status: Recruiting
• Conditions: Sickle Cells Patients
• Intervention / Treatment: Other: Vitamin B12

• Study Type: Observational
• Enrollment (Estimated): 29

Contacts and Locations

• Study Contact: Name: Claire PLUCHART, MD; Phone Number: 0033 0326783357; Email: cpluchart@chu-reims.fr

Study Locations

• France
  • Reims, France, 51092
    • Recruiting
    • Chu Reims
    • Contact: Damien JOLLY; Phone Number: 33 326788472; Email: djolly@chu-reims.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patient hospitalized for a CVO in the follow up of the emergency room visit or in pediatric reanimation

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sickle cells patients exposed to MEOPA; Sickle cells patients exposed to MEOPA during an hospitalization for a CVO	Other: Vitamin B12; Quantification of Vitamin B12

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who will present a Vitamin B12 deficiency	Limit : Vitamin B12 <191pg/mL or homocysteine > 10micromol/L in children under 15 years old or > 15 micromol/L for children over 15 years old.	Day 15

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2024
• Primary Completion (Estimated): November 27, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Anemia, Sickle Cell; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Azoles; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Pyrroles; Macrocyclic Compounds; Tetrapyrroles; Corrinoids; Vitamin B 12
• Other Study ID Numbers: PA24081*

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No