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NCT Number: NCT06570837

Iron Deficincy Among Children With type1 DM in Assiut University Hospital

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

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

About this study

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)

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary School age children with type 1 diabetes from 6 years up to 12year .

Exclusion criteria

  • 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.

Treatment and study plan

Iron

Dietary Supplement

observation effect of iron dificincy

Primary outcomes

  1. 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.

Secondary outcomes

  1. assess the impact of anemic and non anemic iron deficiency in children with type 1 diabetes on their general condition

    Time frame: baseline

    assess the impact of anemic and non anemic iron deficiency in children with type 1 diabetes on their general condition

Study contacts

Contact information is provided by the study sponsor or research team.

Esraa sayed, MD

CONTACT

[email protected]

01003908556

Shimaa kamal

CONTACT

01024982398

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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