- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06615024
Screening of Coexistence Between Sickle Cell Anaemia and G6PD Deficiency
September 24, 2024 updated by: Fatma Hussein Mahmoud
Newborn Screening of Coexistence Between Sickle Cell Anaemia and G6PD Deficiency in NEW VALLEY GOVERNORATE
G6PD deficiency may have a subtle effect on the severity of hemolysis and also worsen the degree of anaemia in SCD when the two disorders coexist.
Therefore, selective decision should be taken in patients in whom the two conditions coexist in the choice of drug and in the treatment of infections.The prevalence of the G-6-PD deficiency is high in SCD patients, but does not differ from that observed among non-SCD subjects .However, the G-6-PD deficiency appears to worsen the clinical features of SCD, there were more hospitalizations, major vaso-occlusive crises among G-6-PD deficient sickle cell patients.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Sickle cell disease (SCD) is not frequent in Egypt except in the Oases where the carrier rate varies from 9 to 22%.
It is a hereditary blood disorder characterized by the production of abnormal hemoglobin molecules that cause red blood cells to take on a crescent or sickle shape.
This haemoglobin called haemoglobin S, which causes red blood cells to become stiff and sticky, leading to various health complications as recurrent pain, fatigue, anaemia, and increased infection susceptibility.prevalence of G6PD deficiency is 4.3% with a male:female ratio of 3.2:1.
Enzyme activity was significantly higher in males than females.
It is located on X chromosome which leads to a lower level of reduced glutathione, an antioxidant, in red blood cells (RBCs).
Most of the time, those who are affected have no symptoms.
However, they should avoid specific triggers that may promote oxidative stress such as fava beans, that may fragilize RBCs and cause hemolysis.
G6PD deficiency may have a subtle effect on the severity of hemolysis and also worsen the degree of anaemia in SCD when the two disorders coexist.
Therefore, selective decision should be taken in patients in whom the two conditions coexist in the choice of drug and in the treatment of infections.
The prevalence of the G-6-PD deficiency is high in SCD patients, but does not differ from that observed among non-SCD subjects .However, the G-6-PD deficiency appears to worsen the clinical features of SCD, there were more hospitalizations, major vaso-occlusive crises among G-6-PD deficient sickle cell patients.
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fatma Hussein Mahmoud, Assistant lecturer
- Phone Number: +2 01062172982
- Email: fh449615@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The study will be conducted on all newborn delivered in pediatric department in NEW VALLEY UNIVERSITY from jan2025 to Jan 2026
Description
Inclusion Criteria:
- All new born with good general health
Exclusion Criteria:
- 1-new born with high reticulocytic count 2-new born with bad general health
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Newborns who are delivered in NEW VALLEY GOVERNORATE
Screening of coexistence between sickle cell anaemia and G6PD deficiency
|
Measuring the enzyme level of G6PD and presence of Hbs
Measuring enzyme level of G6PD and level of HbS
Measuring G6PD enzyme level in neonates and measuring level of HbS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
prevelance of coexistence between sickle cell anaemia and G6PD deficiency in NEW VALLEY GOVERNORATE
Time Frame: One year
|
Evaluate the prevalence of coexistence between sickle cell anaemia and G6PD deficiency in NEW VALLEY GOVERNORATE to create data base for endemic hereditary disease
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Early diagnosis to decrease incidanc of complications
Time Frame: One year
|
Early diagnosis of coexistence between sickle cell anaemia and G6PD deficiency to tell specific treatment and maintain haemoglobin level high to prevent more complications
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2025
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
February 1, 2026
Study Registration Dates
First Submitted
September 24, 2024
First Submitted That Met QC Criteria
September 24, 2024
First Posted (Actual)
September 26, 2024
Study Record Updates
Last Update Posted (Actual)
September 26, 2024
Last Update Submitted That Met QC Criteria
September 24, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Coexistence of SCD and G6PD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sickle Cell Disease and G6PD Deficiency
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Klein Buendel, Inc.National Institute on Minority Health and Health Disparities (NIMHD); Hilton...CompletedSickle Cell Disease | Sickle Cell Anemia in Children | Sickle Cell Thalassemia | Sickle Cell SC DiseaseUnited States
-
Connecticut Children's Medical CenterChildren's Hospital of Philadelphia; National Heart, Lung, and Blood Institute... and other collaboratorsNot yet recruitingSickle Cell Disease | Sickle Cell Disease (SCD) | Sickle Cell Anemia in Children | Sickle Cell | Sickle Cell Anemia (HbSS)United States
-
Nova Laboratories LimitedCompletedSickle Cell Disease | Sickle Cell Hemoglobin C | Sickle Cell-beta-thalassemia | Sickle-Cell; Hemoglobin Disease, ThalassemiaUnited Kingdom, Jamaica
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Academisch Medisch Centrum - Universiteit van Amsterdam...CompletedSickle Cell Disease | Sickle Cell SC Disease | Sickle Cell-SS Disease | Sickle Cell RetinopathyNetherlands
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SangartWithdrawnSickle Cell Disease | Anemia, Sickle Cell | Sickle Cell Anemia | Hemoglobin SC Disease | Sickle Cell Disorders | Sickle Cell Hemoglobin C DiseaseFrance, United Kingdom, Netherlands, Turkey, Bahrain, Belgium, Brazil, Lebanon, Qatar
-
SangartCompletedSickle Cell Disease | Anemia, Sickle Cell | Sickle Cell Anemia | Hemoglobin SC Disease | Sickle Cell Disorders | Sickle Cell Hemoglobin C DiseaseUnited Kingdom, France, Jamaica, Lebanon
-
University of British ColumbiaCompletedSickle Cell Disease | Beta-Thalassemia | Sickle Cell Trait | Sickle Cell-Beta Thalassemia | Sickle Cell-SS DiseaseCanada, Nepal
-
Sidney Kimmel Cancer Center at Thomas Jefferson...National Heart, Lung, and Blood Institute (NHLBI)TerminatedSickle Cell Anemia | Sickle Cell-hemoglobin C Disease | Sickle Cell-β0-thalassemiaUnited States
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University of RegensburgRecruitingSickle Cell Disease | Sickle Cell Anemia | Sickle Cell Disorders | HbS Disease | Hemoglobin S Disease | Sickling Disorder Due to Hemoglobin SGermany, Austria
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Biossil Inc.Not yet recruitingSickle Cell Disease | Sickle Cell Anemia | Sickle Cell Anaemia
Clinical Trials on G6pd enzyme sickling test
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PATHCompletedG6PD DeficiencyUnited States
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PATHUniversity of Oxford; Mahidol UniversityCompletedGlucose-6 Phosphate Dehydrogenase DeficiencyThailand
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University of British ColumbiaCompletedSickle Cell Disease | Beta-Thalassemia | Sickle Cell Trait | Sickle Cell-Beta Thalassemia | Sickle Cell-SS DiseaseCanada, Nepal
-
PATHFundação de Medicina Tropical Dr. Heitor Vieira DouradoCompleted
-
PATHFred Hutchinson Cancer CenterCompletedG6PD DeficiencyUnited States
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Menzies School of Health ResearchIndonesia University; University of Melbourne; Curtin University; Oxford University... and other collaboratorsRecruitingVivax Malaria | G6PD DeficiencyBrazil, Ethiopia, Papua New Guinea
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Sohag UniversityNot yet recruitingSystemic Lupus ErythematosusEgypt
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Tanta UniversityCompletedBiomarkers | Acute Kidney InjurySaudi Arabia
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Sohag UniversityNot yet recruiting