Relationship Between Blood Groups , Iron Deficiency Anemia and Helicobacter Pylori in ChildrenNCT05841433
Relationship Between Blood Groups , Iron Deficiency Anemia and Helicobacter Pylori in Children.
An observational study of Relationship Between Blood Groups , Iron Deficiency Anemia and Helicobacter Pylori in Children, run by Assiut University.
Trial summary
Iron-deficiency anemia (IDA) represents a global public health problem which has a significant impact on human health and social and economic development. Inadequate iron intake, chronic blood loss and impaired iron absorption are among the causes of IDA There are an association between H. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Relationship Between Blood Groups , Iron Deficiency Anemia and Helicobacter Pylori in Children
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 30 Oct 2025
- 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 4 to 18 years
- All sexes
- Child, Adult
Study population: Children from both sexes their ages ranged from 4-18 years diagnosed by H.pylori infection
Who may be able to join
- Children from both sexes their ages ranged from 4-18 years.
- Children who are diagnosed to have H. Pylori infection.
Who cannot join
- Children less than 4 years and more than 18 years.
- Children with chronic illnesses (e.g. CRF, CHF or chronic hemolytic anemias).
- Children who are receiving iron supplementation or multivitamins containing iron.
Trial locations and contacts
No sites are listed yet.
About this study
Iron-deficiency anemia (IDA) represents a global public health problem which has a significant impact on human health and social and economic development. Inadequate iron intake, chronic blood loss and impaired iron absorption are among the causes of IDA There are an association between H. pylori infection and IDA, but the biological explanation for H. pylori infection causing iron-deficiency anemia remains unknown. Initially, sideropenic anemia was considered to be caused by occult blood loss due to chronic superficial active gastritis caused by H. pylori, but subsequent studies did not confirm this theory . H. pylori infection can cause disorders in iron assimilation and increased iron requirements. Hypoacidity caused by pangastritis and a low level of ascorbic acid in the stomach of patients infected with H. pylori may affect the absorption of iron in the duodenum . In addition, levels of lactoferrin gastric mucosa (an iron-binding protein) are high in patients infected with iron-deficient H. pylori, showing a possible role between increased lactoferrin sequestration and iron utilization by the body . H. pylori also competes with the host for available food grade iron. H. pylori has several iron acquisition systems, which can capture iron available in the microenvironment of the stomach lumen . Moreover, there are studies that indicate that an iron-deficiency anemia which does not respond to iron therapy can be resolved by eradicating H. pylori from the stomach . ABO blood group seem to be looked into as risks for H. pylori related stomach malignancy, nevertheless, there are actually inconsistent scientific studies because of numerous confounding outcomes. Blood group antigens have the receptor properties for toxins, parasitic organisms and bacteria, exactly where this bacteria could assist in annexation or intrusion and avert multitude approval components .
Read the detailed description
Iron-deficiency anemia (IDA) represents a global public health problem which has a significant impact on human health and social and economic development. Inadequate iron intake, chronic blood loss and impaired iron absorption are among the causes of IDA There are an association between H. pylori infection and IDA, but the biological explanation for H. pylori infection causing iron-deficiency anemia remains unknown. Initially, sideropenic anemia was considered to be caused by occult blood loss due to chronic superficial active gastritis caused by H. pylori, but subsequent studies did not confirm this theory . H. pylori infection can cause disorders in iron assimilation and increased iron requirements. Hypoacidity caused by pangastritis and a low level of ascorbic acid in the stomach of patients infected with H. pylori may affect the absorption of iron in the duodenum . In addition, levels of lactoferrin gastric mucosa (an iron-binding protein) are high in patients infected with iron-deficient H. pylori, showing a possible role between increased lactoferrin sequestration and iron utilization by the body . H. pylori also competes with the host for available food grade iron. H. pylori has several iron acquisition systems, which can capture iron available in the microenvironment of the stomach lumen . Moreover, there are studies that indicate that an iron-deficiency anemia which does not respond to iron therapy can be resolved by eradicating H. pylori from the stomach . ABO blood group seem to be looked into as risks for H. pylori related stomach malignancy, nevertheless, there are actually inconsistent scientific studies because of numerous confounding outcomes. Blood group antigens have the receptor properties for toxins, parasitic organisms and bacteria, exactly where this bacteria could assist in annexation or intrusion and avert multitude approval components .
- Conditions
- Relationship Between Blood Groups , Iron Deficiency Anemia and Helicobacter Pylori in Children
- Medical subject headings
- Anemia, Iron-Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of seropositive helicopacter pylori infection and the frequencies of ABO blood groups and iron deficiency anemia in helicopacter pylori seropositive children.
by Lohman technique , height and weight were recorded for children without shoes and wearing light clothes, standing straight, with their weight uniformly distributed on both feet and their arms hanging freely on the sides. A digital scale (model 881; Seca, Hamburg, Germany).
Height measurements in centimeters. Body mass index (BMI) to age was obtained. Anemia was defined according to (WHO) age criteria; that is, hemoglobin level of <11 g/dL (110 g/L) in children <5 years, <11.5 g/dL (115 g/L) in children with ages between 5 and 12 years and <12 g/dL (120 g/L) for patients with ages between 12 and 18 years old. Serum ferritin level was measured using electro chemiluminescence (Elec Sys 2010 analyzer; Roche Diagnostics, Mannheim, Germany), and Serum iron level and total iron binding capacity (TIBC) were determined by CobasIntegra700 analyzer (Roche Diagnostics, Basel, Switzerland). Iron deficiency anemia (IDA) was defined as serum ferritin level of <-2SD for age.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relationship Between Blood Groups , Iron Deficiency Anemia and Helicobacter Pylori in ChildrenStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Abdelhak Shehab, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841433
- Sponsor's protocol ID
- 357357
- Status last verified
- May 2023
- First submitted
- 25 Jan 2023
- Last updated
- 3 May 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Blood Groups , Iron Deficiency Anemia and Helicobacter Pylori in Children.
- ClinicalTrials.gov ID
- NCT05841433
- Acronym / sponsor ID
- 357357
- Conditions
- Relationship Between Blood Groups , Iron Deficiency Anemia and Helicobacter Pylori in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 3 May 2023 (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.
Iron-deficiency anemia (IDA) represents a global public health problem which has a significant impact on human health and social and economic development. Inadequate iron intake, chronic blood loss and impaired iron absorption are among the causes of IDA There are an association between H. pylori infection and IDA, but the biological explanation for H. pylori infection causing iron-deficiency anemia remains unknown. Initially, sideropenic anemia was considered to be caused by occult blood loss due to chronic superficial active gastritis caused by H. pylori, but subsequent studies did not confirm this theory . H. pylori infection can cause disorders in iron assimilation and increased iron requirements. Hypoacidity caused by pangastritis and a low level of ascorbic acid in the stomach of patients infected with H. pylori may affect the absorption of iron in the duodenum . In addition, levels of lactoferrin gastric mucosa (an iron-binding protein) are high in patients infected with iron-deficient H. pylori, showing a possible role between increased lactoferrin sequestration and iron utilization by the body . H. pylori also competes with the host for available food grade iron. H. pylori has several iron acquisition systems, which can capture iron available in the microenvironment of the stomach lumen . Moreover, there are studies that indicate that an iron-deficiency anemia which does not respond to iron therapy can be resolved by eradicating H. pylori from the stomach . ABO blood group seem to be looked into as risks for H. pylori related stomach malignancy, nevertheless, there are actually inconsistent scientific studies because of numerous confounding outcomes. Blood group antigens have the receptor properties for toxins, parasitic organisms and bacteria, exactly where this bacteria could assist in annexation or intrusion and avert multitude approval components .
Detailed description
Iron-deficiency anemia (IDA) represents a global public health problem which has a significant impact on human health and social and economic development. Inadequate iron intake, chronic blood loss and impaired iron absorption are among the causes of IDA There are an association between H. pylori infection and IDA, but the biological explanation for H. pylori infection causing iron-deficiency anemia remains unknown. Initially, sideropenic anemia was considered to be caused by occult blood loss due to chronic superficial active gastritis caused by H. pylori, but subsequent studies did not confirm this theory . H. pylori infection can cause disorders in iron assimilation and increased iron requirements. Hypoacidity caused by pangastritis and a low level of ascorbic acid in the stomach of patients infected with H. pylori may affect the absorption of iron in the duodenum . In addition, levels of lactoferrin gastric mucosa (an iron-binding protein) are high in patients infected with iron-deficient H. pylori, showing a possible role between increased lactoferrin sequestration and iron utilization by the body . H. pylori also competes with the host for available food grade iron. H. pylori has several iron acquisition systems, which can capture iron available in the microenvironment of the stomach lumen . Moreover, there are studies that indicate that an iron-deficiency anemia which does not respond to iron therapy can be resolved by eradicating H. pylori from the stomach . ABO blood group seem to be looked into as risks for H. pylori related stomach malignancy, nevertheless, there are actually inconsistent scientific studies because of numerous confounding outcomes. Blood group antigens have the receptor properties for toxins, parasitic organisms and bacteria, exactly where this bacteria could assist in annexation or intrusion and avert multitude approval components .
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children from both sexes their ages ranged from 4-18 years diagnosed by H.pylori infection
Key inclusion criteria (2 listed)
- Children from both sexes their ages ranged from 4-18 years.
- Children who are diagnosed to have H. Pylori infection.
Key exclusion criteria (3 listed)
- Children less than 4 years and more than 18 years.
- Children with chronic illnesses (e.g. CRF, CHF or chronic hemolytic anemias).
- Children who are receiving iron supplementation or multivitamins containing iron.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of seropositive helicopacter pylori infection and the frequencies of ABO blood groups and iron deficiency anemia in helicopacter pylori seropositive children.
Time frame: baseline
by Lohman technique , height and weight were recorded for children without shoes and wearing light clothes, standing straight, with their weight uniformly distributed on both feet and their arms hanging freely on the sides. A digital scale (model 881; Seca, Hamburg, Germany). Height measurements in centimeters. Body mass index (BMI) to age was obtained. Anemia was defined according to (WHO) age criteria; that is, hemoglobin level of <11 g/dL (110 g/L) in children <5 years, <11.5 g/dL (115 g/L) in children with ages between 5 and 12 years and <12 g/dL (120 g/L) for patients with ages between 12 and 18 years old. Serum ferritin level was measured using electro chemiluminescence (Elec Sys 2010 analyzer; Roche Diagnostics, Mannheim, Germany), and Serum iron level and total iron binding capacity (TIBC) were determined by CobasIntegra700 analyzer (Roche Diagnostics, Basel, Switzerland). Iron deficiency anemia (IDA) was defined as serum ferritin level of <-2SD for age.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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 Relationship Between Blood Groups , Iron Deficiency Anemia and Helicobacter Pylori in Children, run by Assiut University.
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 2 inclusion and 3 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 3 May 2023. 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 Aliaa AB shehab, Bachelor's (01064480804, aliaashehab812@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of seropositive helicopacter pylori infection and the frequencies of ABO blood groups and iron deficiency anemia in helicopacter pylori seropositive children. (time frame: baseline). 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 3 May 2023.