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临床试验/NCT02858505
NCT02858505已完成2 期

Impact of One Versus Two Amino Acid Chelated Iron Capsules on Prevention of Iron Deficiency Anemia in Non-anemic Women With Twin Gestations

Assiut University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
120
试验地点
1
主要终点
Hemoglobin level

研究概览

简要总结

Anaemia is the most worldwide health problem affecting pregnant women in both developed and developing countries. During pregnancy there is an inconsistent increase in plasma volume and haemoglobin mass.

Iron deficiency anemia is the commonest type of anemia during pregnancy. The pregnant woman needs about 1000 mg of iron during pregnancy.

Diet alone cannot give pregnant woman the daily required amount of the iron (about 27 mg/day) so the Centers for Disease Control and Prevention recommend that pregnant women take a daily supplement of 30 mg of elemental iron as a preventive dose. As most women begin their pregnancy with low iron stores, particularly in the second and third trimesters, so prevention should start as soon as possible even before pregnancy to prevent depletion of iron store and further Iron deficiency anemia.

Oral iron is a cheap, effective and relatively safe line to prevent Iron deficiency anemia during pregnancy. The common available ferrous salts include ferrous fumarate, ferrous sulphate and ferrous gluconate. Unfortunately; these iron forms are associated usually with constipation, darkened stools, diarrhea, loss of appetite, nausea, stomach cramps, and vomiting.

Iron amino acid chelates have been emerged to be used as agents for prevention and treatment of Iron deficiency anemia. These agents provide maximum bioavailability and maximum efficacy with minimal unpleasant side effects.

Twin pregnancies have a significant role in perinatal morbidity due to increased risks of low birth weight and preterm birth. The iron requirement for twin pregnancy is probable double fold that of a singleton pregnancy and maternal hemoglobin in twin gestations is usually lower than in singleton pregnancy resulting in higher rate of Iron deficiency anemia.

研究设计

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

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • twin gestations
  • ±12 weeks)
  • normal hemoglobin level (Hb ≥ 120 g/L).
  • women were living in nearby area to make up follow up quit possible
  • willing to participate in our study

排除标准

  • a recent blood transfusion
  • threatened miscarriage
  • pathological blood loss
  • vegetarian diet
  • intolerant to oral iron form
  • history of haematologic disorder
  • chronic diseases
  • unwillingness to co-operate.

研究组 & 干预措施

27 mg elemental iron group

Active Comparator

received 27 mg elemental iron once daily starting at 12 weeks until 36 weeks

干预措施: 27 mg elemental iron (Drug)

54 mg elemental iron group

Active Comparator

received 54 mg elemental iron once daily starting at 12 weeks until 36 weeks

干预措施: 54 mg elemental iron (Drug)

结局指标

主要结局

Hemoglobin level

时间窗: 24 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Khairy Ali

Dr

Assiut University

研究点 (1)

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