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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Aliaa AB shehab, Bachelor's contact

01064480804

aliaashehab812@gmail.com

shaaban RD Helal, prof contact

01005688567

elhelal2007@gmail.com

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 .

Medical subject headings
Anemia, Iron-Deficiency

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted3 May 2023
  2. Study start1 Jun 2023 (estimated)
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion30 Oct 2025 (estimated)

Resources

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)
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

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.

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