Sickle Cell Disease and G6PD DeficiencyNCT06615024
Screening of Coexistence Between Sickle Cell Anaemia and G6PD Deficiency
An observational study of Sickle Cell Disease and G6PD Deficiency, run by Fatma Hussein Mahmoud.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease and G6PD Deficiency
- What is being tested?
- G6pd enzyme sickling test, G6PD enzyme and sickling test and G6PD enzyme and HPLC
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Feb 2026
- 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 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study will be conducted on all newborn delivered in pediatric department in NEW VALLEY UNIVERSITY from jan2025 to Jan 2026
Who may be able to join
- All new born with good general health
Who cannot join
- 1-new born with high reticulocytic count 2-new born with bad general health
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sickle Cell Disease and G6PD Deficiency
- Being tested
- G6pd enzyme sickling test, G6PD enzyme and sickling test, G6PD enzyme and HPLC
- Medical subject headings
- Anemia, Sickle Cell, Glucosephosphate Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G6pd enzyme sickling testDiagnostic test
Measuring the enzyme level of G6PD and presence of Hbs
G6PD enzyme and sickling testDiagnostic test
Measuring enzyme level of G6PD and level of HbS
G6PD enzyme and HPLCDiagnostic test
Measuring G6PD enzyme level in neonates and measuring level of HbS
| Study group | Role | What they receive |
|---|---|---|
| Newborns who are delivered in NEW VALLEY GOVERNORATE | Screening of coexistence between sickle cell anaemia and G6PD deficiency Receives: Diagnostic Test: G6pd enzyme sickling test; Diagnostic Test: G6PD enzyme and sickling test; Diagnostic Test: G6PD enzyme and HPLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevelance of coexistence between sickle cell anaemia and G6PD deficiency in NEW VALLEY GOVERNORATE
Evaluate the prevalence of coexistence between sickle cell anaemia and G6PD deficiency in NEW VALLEY GOVERNORATE to create data base for endemic hereditary disease
Measured: One year
Secondary outcomes (1)
Early diagnosis to decrease incidanc of complications
Early diagnosis of coexistence between sickle cell anaemia and G6PD deficiency to tell specific treatment and maintain haemoglobin level high to prevent more complications
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study startJan 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell Disease and G6PD DeficiencyStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatma Hussein Mahmoud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fatma Hussein Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615024
- Sponsor's protocol ID
- Coexistence of SCD and G6PD
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 26 Sep 2024
- 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 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Newborn Screening of Coexistence Between Sickle Cell Anaemia and G6PD Deficiency in NEW VALLEY GOVERNORATE
- ClinicalTrials.gov ID
- NCT06615024
- Acronym / sponsor ID
- Coexistence of SCD and G6PD
- Conditions
- Sickle Cell Disease and G6PD Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fatma Hussein MahmoudUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 26 Sep 2024 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborns who are delivered in NEW VALLEY GOVERNORATE | – | Diagnostic Test: G6pd enzyme sickling test, Diagnostic Test: G6PD enzyme and sickling test, Diagnostic Test: G6PD enzyme and HPLCScreening of coexistence between sickle cell anaemia and G6PD deficiency |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study will be conducted on all newborn delivered in pediatric department in NEW VALLEY UNIVERSITY from jan2025 to Jan 2026
Key inclusion criteria (1 listed)
- All new born with good general health
Key exclusion criteria (1 listed)
- 1-new born with high reticulocytic count 2-new born with bad general health
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 |
|---|---|---|
| G6pd enzyme sickling testMeasuring the enzyme level of G6PD and presence of Hbs | Diagnostic test | Newborns who are delivered in NEW VALLEY GOVERNORATE |
| G6PD enzyme and sickling testMeasuring enzyme level of G6PD and level of HbS | Diagnostic test | Newborns who are delivered in NEW VALLEY GOVERNORATE |
| G6PD enzyme and HPLCMeasuring G6PD enzyme level in neonates and measuring level of HbS | Diagnostic test | Newborns who are delivered in NEW VALLEY GOVERNORATE |
Primary outcome
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
1 secondary outcome
Early diagnosis to decrease incidanc of complications
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease and G6PD Deficiency, run by Fatma Hussein Mahmoud.
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 1 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: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Hussein Mahmoud, Assistant lecturer (01062172982 ext. +2, fh449615@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevelance of coexistence between sickle cell anaemia and G6PD deficiency in NEW VALLEY GOVERNORATE (time frame: One year). 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 26 Sep 2024.