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Набор скоро начнётся NCT07657091

COMPARISON OF EFFICACY OF ORAL VS IV IRON THERAPY IN CHILDREN AGED 12-59 MONTHS, WITH IRON DEFICIENCY ANEMIA

Фаза II С лечением Iron Deficiency Anemia in Children

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Oral ferrous sulfate, iron sucrose.
Кому может быть актуально
Состояния в реестре: Iron Deficiency Anemia in Children. Базовые параметры: 12 мес. — 59 мес. · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Пакистан
Следующий шаг
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Обзор

Comparison of Efficacy of Oral versus Intravenous Iron Therapy in Children Aged 12-59 Months with Iron Deficiency Anemia: A Randomized Controlled Trial Iron deficiency anemia (IDA) remains one of the most common nutritional disorders among children worldwide and is a major public health concern in developing countries, including Pakistan. Children under five years of age are particularly vulnerable due to rapid growth and increased iron requirements. IDA can adversely affect cognitive development, motor performance, behavior, immunity, and overall growth. Oral iron supplementation is currently the standard treatment for pediatric IDA because of its affordability and ease of administration. However, its effectiveness is often limited by gastrointestinal side effects, poor palatability, prolonged treatment duration, and poor adherence. Intravenous iron therapy offers an alternative approach that may provide faster correction of anemia and replenishment of iron stores while avoiding some of the limitations associated with oral therapy. Although intravenous iron preparations have demonstrated promising results in several settings, comparative data among young children remain limited. This randomized controlled trial aims to compare the efficacy and safety of oral iron therapy and intravenous iron sucrose therapy in children aged 12-59 months with moderate iron deficiency anemia. The findings of this study may help identify the most effective and practical treatment strategy for this high-risk population.

Подробное описание

Iron deficiency anemia is a leading cause of morbidity among children under five years of age and continues to contribute substantially to poor child health outcomes in low- and middle-income countries. Early childhood is a critical period for growth and neurodevelopment, and iron deficiency during this stage may result in long-term adverse effects on cognitive function, psychomotor development, behavior, and immunity.

Oral iron supplementation remains the standard treatment for iron deficiency anemia; however, treatment success is frequently affected by poor adherence resulting from gastrointestinal side effects, unpleasant taste, prolonged treatment duration, and inconsistent caregiver administration. These limitations may delay hematologic recovery and restoration of iron stores.

Intravenous iron sucrose has emerged as a potential alternative for the treatment of iron deficiency anemia. It allows direct replenishment of iron stores, may achieve a more rapid increase in hemoglobin levels, and eliminates issues related to gastrointestinal absorption and daily medication adherence. Despite these potential advantages, evidence comparing intravenous and oral iron therapy in young children is limited, particularly in resource-constrained settings.

This randomized controlled trial will evaluate and compare the effectiveness and safety of oral iron therapy and intravenous iron sucrose therapy in children aged 12-59 months diagnosed with moderate iron deficiency anemia. The study findings are expected to provide locally relevant evidence to support clinical decision-making and optimize treatment strategies for pediatric iron deficiency anemia.

Вмешательства

  • Препарат Oral ferrous sulfate
    Administration of oral ferrous sulfate at a dose of 3-6 mg/kg/day of elemental iron for treatment of iron deficiency anemia.
  • Препарат iron sucrose
    Administration of intravenous iron sucrose according to the calculated iron deficit under medical supervision. (Ganzoni formula)

Первичные конечные точки

  • increase in hb from baseline [Срок оценки: 6 months]

Критерии участия

Inclusion Criteria:•

. Age 12-59 months.

  • Diagnosed with moderate iron deficiency anemia
  • Hemoglobin level 7-9.9 g/dL
  • Parents or guardians willing to provide informed consent

Exclusion Criteria:•

  • Mild anemia and Severe anemia (Hb <7 g/dL)/ requiring blood transfusion
  • Known hemoglobinopathies (e.g., thalassemia)
  • Acute severe infection or inflammatory disease
  • Previous iron therapy within the last 4 weeks/ Blood transfusion
  • Known hypersensitivity to iron preparations
  • Those who are not willing to participate.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Пакистан · 1 центр
  • Kharadar General Hospital — Karachi

Публикации

  • Lozoff B. Iron deficiency and child development. Food Nutr Bull. 2007 Dec;28(4 Suppl):S560-71. doi: 10.1177/15648265070284S409. PMID 18297894

Идентификаторы

NCT: NCT07657091 · KGH-ERB:2026/02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗