The Effect of Iron Deficiency Anemia During Pregnancy
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Assiut University
临床试验: NCT02590224
BioSeek: NCT02590224
关键词
抽象
Iron deficiency anemia during pregnancy is a significant worldwide health problem, affecting 22% of pregnant women in industrialized countries and 52% in non-industrialized countries. Iron deficiency anemia during pregnancy is associated with increased maternal as well as fetal morbidity, including prematurity, low birth-weight and perinatal and infant loss. Therefore, routine iron supplementation during the second half of pregnancy has been recommended once daily. Others, however, support a selective iron supplementation only for women with iron deficiency anemia, in order to avoid the increased risk of haemoconcentration associated with routine iron supplementation. Unfortunately, compliance to either iron-supplementation programs, especially among pregnant women, is poor, due in part to the side effects associated with these preparations.
Currently, there are many iron preparations available containing different types of iron salts, including ferrous sulfate, ferrous fumarate, ferrous ascorbate but common adverse drug reactions found with these preparations are mainly gastrointestinal intolerance like nausea, vomiting, constipation, diarrhea, abdominal pain, while ferrous bis-glycinate (fully reacted chelated amino acid form of iron) rarely make complication.
Product resulting from the reaction of a metal ion from a soluble salt with amino acids to form coordinate covalent bonds, the resulting molecule is called as chelate and chemical bonding process is called chelation. Ferrous bis-glycinate is highly stable and totally nutritionally functional chelate it is an amino acid fully reacted chelate which is formed by the binding of two molecules of glycine to one Fe2+ atom.
日期
最后验证: | 02/28/2018 |
首次提交: | 10/26/2015 |
提交的预估入学人数: | 10/26/2015 |
首次发布: | 10/27/2015 |
上次提交的更新: | 03/16/2018 |
最近更新发布: | 03/19/2018 |
实际学习开始日期: | 12/31/2015 |
预计主要完成日期: | 06/30/2017 |
预计完成日期: | 11/30/2017 |
状况或疾病
Iron Deficiency Anemia
干预/治疗
Drug: Ferrous bis-glycinate group
Drug: Ferrous glycine sulphate group
相
相 4
手臂组
臂 | 干预/治疗 |
---|---|
Active Comparator: Ferrous bis-glycinate group The patients will receive oral ferrous bis-glycinate fully reacted amino acid 27 mg tablets (Pharaferro 27 tablets) once daily for eight consecutive weeks. | Drug: Ferrous bis-glycinate group |
Active Comparator: Ferrous glycine sulphate group The patients will receive 567.6 mg of ferrous glycine sulphate capsules (Ferrosanol duodenale capsules, Schwarz) once daily for eight consecutive weeks. | Drug: Ferrous glycine sulphate group |
资格标准
有资格学习的年龄 | 20 Years 至 20 Years |
有资格学习的性别 | Female |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: 1. Singleton pregnancy. 2. Gestational age 14-18 weeks. 3. Mild to moderate anemia 4. No associated medical or obstetric complications. 5. Women not already receiving iron therapy. 6. Women accepted to participate in the study. Exclusion Criteria: 1. Multiple pregnancy 2. Severe anemia 3. Iron hypersensitivity. 4. Liver diseases. 5. Women refuse to participate in the study. |
结果
主要结果指标
1. the rate of increase of Hemoglobin level [8 weeks]
difference in hemoglobin concentrations before and after treatment