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临床试验/NCT06590831
NCT06590831已完成不适用

Lactoferrin Alone ,Iron Alone Vs Lactoferrin Plus Iron for Treatment of Iron Deficiency Anemia During the 3rd Trimester of Pregnancy (Randomized Controlled Trial)

Egymedicalpedia1 个研究点 分布在 1 个国家目标入组 399 人开始时间: 2023年6月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
399
试验地点
1
主要终点
Treatment of Anemia

研究概览

简要总结

Iron deficiency (ID) and iron deficiency anemia (IDA) are the most common iron disorders throughout the world.

ID and IDA, particularly caused by increased iron requirements during pregnancy; represent a high risk for preterm delivery, fetal growth retardation, low birth weight, and inferior neonatal health. These pregnancy complications are thought to occur because of an increased iron requirement, related to enhanced blood volume and development of the fetoplacental unit.

详细描述

The World Health Organization (WHO) defines anemia in pregnancy as a hemoglobin (Hb) concentration of < 11 g/dl. Centers for disease control &prevention determine a cut of -off point 10.5 g/dl during 2nd trimester for diagnosis of IDA.

Iron deficiency anemia (IDA) is the most common type of anemia in pregnancy. The iron content of the body is normally kept constant by regulating the amount absorbed to balance the amount lost.

The WHO estimates that 46% of pregnant women in African region, 38% in Eastern Mediterranean region, 25% in European region and 24% in the region of the Americas are anemic mainly because of iron deficiency. Anemia is a common medical disorder affecting a lot of women in pregnancy in the developing countries.

Management of anemia remain an important issue in prenatal medicine. Correct diagnosis and treatment lead to effective management of fetal and maternal risk and improved prenatal outcome. Diet alone can't supply the 30-40 mg iron that is required for absorption of 4-6mg iron per day needed during the later stage of pregnancy so iron supplementation is strongly recommended for all females in developing countries.

Traditional therapeutic options of iron deficiency anemia during pregnancy were administration of oral iron shows lack of compliance and side effects and often limited intestinal absorption and bioavailability. The most used treatment for ID and IDA currently consists of oral administration of iron as ferrous sulphate. However, ferrous sulphate administration often fails to exert any significant effects on these pregnancy-associated pathologies, and frequently causes several adverse effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women with single fetus
  • All pregnant women in 3rd trimester (28w_36w) complaining of mild IDA
  • Iron Deficiency Anemia mild anemia (hemoglobin level < 11 mg/dl , and serum ferritin level < 12 mg/dl).

排除标准

  • Patients with a history of anemia due to any other causes such as chronic blood loss, hemolytic anemia, and thalassemia.
  • Clinical and/or laboratory evidence of hepatic, renal, cardiovascular abnormalities.
  • History of peptic disorders.
  • Esophagitis
  • Hiatal hernia
  • Malabsorption syndrome

研究组 & 干预措施

Group A: (lactoferrin Group)

Active Comparator

About 133 anemic pregnant women will be treated with lactoferrin only (pravotin 100mg ) twice daily for 4 weeks.

干预措施: Lactoferrin (Drug)

Group B: (Amino acid chelated iron Group)

Active Comparator

About 133 anemic pregnant women will be treated with amino acid chelated iron only (phara fero 27) once daily for 4 weeks.

干预措施: Lactoferrin (Drug)

Group C: (lactoferrin with amino acid chelated iron Group)

Active Comparator

About 133 anemic pregnant women will be treated with lactoferrin with amino acid chelated iron (phara fero 27 plus ) once daily for 4 weeks

干预措施: Lactoferrin (Drug)

结局指标

主要结局

Treatment of Anemia

时间窗: 6 months

Efficacy of lactoferrin alone and lactoferrin with iron for treatment of iron deficiency anemia during 3rd trimester of pregnancy by measuring the hemoglobin level before and after treatment

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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