Iron Deficiency, Anaemia in Children Type1DMNCT06570837
Iron Deficincy Among Children With type1 DM in Assiut University Hospital
An observational study of Iron Deficiency, Anaemia in Children Type1DM, run by Assiut University.
Trial summary
detect the prevelance of anemic and non anemic iron deficiency in children with type 1 diabetes.assess the impact of anemic and non anemic iron deficiency in children with type 1 diabetes on their general condition Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Iron Deficiency, Anaemia in Children Type1DM
- What is being tested?
- Iron
- How many people
- 141 participants
- Where
- No sites listed yet
- Study dates
- 1 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 6 to 12 years
- All sexes
- Child
Study population: cross sectional
Who may be able to join
- Primary School age children with type 1 diabetes from 6 years up to 12year .
Who cannot join
- 1-All children with type1 diabetes less than 6 years and above 12 years. 2-Exclude other autoimmune diseases associated with diabetes mellitus (hypothyroidism, Addison disease , pernicious anemia, Celiac disease).
- 3-Any condition affecting iron metabolism.
Trial locations and contacts
No sites are listed yet.
Shimaa kamal contact
About this study
detect the prevelance of anemic and non anemic iron deficiency in children with type 1 diabetes.assess the impact of anemic and non anemic iron deficiency in children with type 1 diabetes on their general condition
Read the detailed description
Anemic and non anemic iron deficiency : is a global public health problem affecting both developing and developed countries with major consequences for human health as well as social and economic development.Iron deficiency anemia (IDA) appears to be more common in diabetic patients compared to non-diabetic population ,Iron deficiency (ID) and IDA can impair glucose homeostasis in human and may negatively affect glycemic control and predispose to more complications in diabetic patients. On the other hand diabetes and its complications are associated with anemia and its correction improves diabetes control and may prevent or delay the occurrence of complications. (1) Iron-deficiency anemia is the most common type of anemia. It occurs when your body doesn't have enough iron, which your body needs to make hemoglobin. When there isn't enough iron in your blood, the rest of your body can't get the amount of oxygen it needs.(2) Iron-deficiency anemia may be present without a person experiencing symptoms. (3) It tends to develop slowly; therefore the body has time to adapt, and the disease often goes unrecognized for some time. (4) If symptoms present, patients may present with the sign of pallor (reduced oxyhemoglobin in skin or mucous membranes),(5) and the symptoms of feeling tired, weak, dizziness, lightheadedness, poor physical exertion, headaches, decreased ability to concentrate, cold hands and feet, cold sensitivity, increased thirst and confusion. (6)(7) None of these symptoms (or any of the others below) are sensitive or specific. In severe cases, shortness of breath can occur. (8) Pica may also develop; of which consumption of ice, known as pagophagia, has been suggested to be the most specific for iron deficiency anemia.(9)
Iron deficiency without anaemia has been associated with:
- weakness, fatigue, reduced exercise performance, difficulty in concentrating, and poor work productivity(10)
- neurocognitive dysfunction including irritability(11)
- fibromyalgia syndrome(12)
- restless legs syndrome(13)
- symptom persistence in patients treated for hypothyroidism(14)
- poor neurodevelopmental outcomes in infants born to mothers with iron deficiency.(15)
Iron-deficiency anemia is confirmed by tests that include serum ferritin, serum iron level, serum transferrin, and total iron binding capacity. (16) A low serum ferritin is most commonly found. However, serum ferritin can be elevated by any type of chronic inflammation and thus is not consistently decreased in iron-deficiency anemia.(17) Serum iron levels may be measured, but serum iron concentration is not as reliable as the measurement of both serum iron and serum iron-binding protein levels. (18) The percentage of iron saturation (or transferrin saturation index or percent) can be measured by dividing the level of serum iron by total iron binding capacity and is a value that can help to confirm the diagnosis of iron-deficiency anemia; however, other conditions must also be considered, including other types of anemia.(19)
- Being tested
- Iron
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IronDietary supplement
observation effect of iron dificincy
What is being measured
The primary outcome is the main question the study is designed to answer.
detect the prevelance of anemic and non anemic iron deficiency in children with type 1 diabetes.
detect the prevelance of anemic and non anemic iron deficiency in children with type 1 diabetes.
Measured: baseline
Secondary outcomes (1)
assess the impact of anemic and non anemic iron deficiency in children with type 1 diabetes on their general condition
assess the impact of anemic and non anemic iron deficiency in children with type 1 diabetes on their general condition
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Jan 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency, Anaemia in Children Type1DMStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Sayed Ahmed Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570837
- Sponsor's protocol ID
- Iron deficieny in type 1 DM
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rubenstein MD, Wall RT. Clinical use of beta-thromboglobulin levels in diagnosing and treating consumptive and immune thrombocytopenia. Am J Hematol. 1981 Jun;10(4):369-73. doi: 10.1002/ajh.2830100406.
PubMed 6166192
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Deficincy Among Children With type1 DM in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT06570837
- Acronym / sponsor ID
- Iron deficieny in type 1 DM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 26 Aug 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.
detect the prevelance of anemic and non anemic iron deficiency in children with type 1 diabetes.assess the impact of anemic and non anemic iron deficiency in children with type 1 diabetes on their general condition
Detailed description
Anemic and non anemic iron deficiency : is a global public health problem affecting both developing and developed countries with major consequences for human health as well as social and economic development.Iron deficiency anemia (IDA) appears to be more common in diabetic patients compared to non-diabetic population ,Iron deficiency (ID) and IDA can impair glucose homeostasis in human and may negatively affect glycemic control and predispose to more complications in diabetic patients. On the other hand diabetes and its complications are associated with anemia and its correction improves diabetes control and may prevent or delay the occurrence of complications. (1) Iron-deficiency anemia is the most common type of anemia. It occurs when your body doesn't have enough iron, which your body needs to make hemoglobin. When there isn't enough iron in your blood, the rest of your body can't get the amount of oxygen it needs.(2) Iron-deficiency anemia may be present without a person experiencing symptoms. (3) It tends to develop slowly; therefore the body has time to adapt, and the disease often goes unrecognized for some time. (4) If symptoms present, patients may present with the sign of pallor (reduced oxyhemoglobin in skin or mucous membranes),(5) and the symptoms of feeling tired, weak, dizziness, lightheadedness, poor physical exertion, headaches, decreased ability to concentrate, cold hands and feet, cold sensitivity, increased thirst and confusion. (6)(7) None of these symptoms (or any of the others below) are sensitive or specific. In severe cases, shortness of breath can occur. (8) Pica may also develop; of which consumption of ice, known as pagophagia, has been suggested to be the most specific for iron deficiency anemia.(9)
Iron deficiency without anaemia has been associated with:
- weakness, fatigue, reduced exercise performance, difficulty in concentrating, and poor work productivity(10)
- neurocognitive dysfunction including irritability(11)
- fibromyalgia syndrome(12)
- restless legs syndrome(13)
- symptom persistence in patients treated for hypothyroidism(14)
- poor neurodevelopmental outcomes in infants born to mothers with iron deficiency.(15)
Iron-deficiency anemia is confirmed by tests that include serum ferritin, serum iron level, serum transferrin, and total iron binding capacity. (16) A low serum ferritin is most commonly found. However, serum ferritin can be elevated by any type of chronic inflammation and thus is not consistently decreased in iron-deficiency anemia.(17) Serum iron levels may be measured, but serum iron concentration is not as reliable as the measurement of both serum iron and serum iron-binding protein levels. (18) The percentage of iron saturation (or transferrin saturation index or percent) can be measured by dividing the level of serum iron by total iron binding capacity and is a value that can help to confirm the diagnosis of iron-deficiency anemia; however, other conditions must also be considered, including other types of anemia.(19)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- cross sectional
Key inclusion criteria (1 listed)
- Primary School age children with type 1 diabetes from 6 years up to 12year .
Key exclusion criteria (2 listed)
- 1-All children with type1 diabetes less than 6 years and above 12 years. 2-Exclude other autoimmune diseases associated with diabetes mellitus (hypothyroidism, Addison disease , pernicious anemia, Celiac disease).
- 3-Any condition affecting iron metabolism.
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 |
|---|---|---|
| Ironobservation effect of iron dificincy | Dietary supplement | – |
Primary outcome
detect the prevelance of anemic and non anemic iron deficiency in children with type 1 diabetes.
Time frame: baseline
detect the prevelance of anemic and non anemic iron deficiency in children with type 1 diabetes.
1 secondary outcome
assess the impact of anemic and non anemic iron deficiency in children with type 1 diabetes on their general condition
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Background: PubMed 6166192Rubenstein MD, Wall RT. Clinical use of beta-thromboglobulin levels in diagnosing and treating consumptive and immune thrombocytopenia. Am J Hematol. 1981 Jun;10(4):369-73. doi: 10.1002/ajh.2830100406.
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.
Shimaa kamal contact
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency, Anaemia in Children Type1DM, 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 1 inclusion and 2 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 Aug 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 Esraa sayed, MD (01003908556, esrasayed567@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detect the prevelance of anemic and non anemic iron deficiency in children with type 1 diabetes. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06570837, which also lists 1 linked publication.
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 Aug 2024.