An Early Phase 1 interventional study of amino acid chelated iron and iron salt (ferrous fumarate) in Iron Deficiency Anemia of Pregnancy, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2015-07-28.
Sponsored by Cairo University · Early Phase 1, Interventional, and Treatment
Iron deficiency anemia is a very common problem accompanying pregnancy. in this study, the investigators are going to compare the efficacy and tolerability of two preparations of oral iron in treatment of iron deficiency anemia with pregnancy.
In this study, the investigators are going to compare two preparations of oral iron in treatment of iron deficiency anemia with pregnancy. a total of 300 pregnant women will be randomly divided into two equal groups (each containing 150 pregnant woman). one group will receive amino acid chelated iron and the other group will receive iron salt (ferrous fumarate). All pregnant women attending the obstetrics outpatient clinic of kasr al aini hospital at 14-18 weeks gestation will be submitted to complete blood picture and serum ferritin. those who prove to have iron deficiency anemia (hemoglobin less than 11g/dl and serum ferritin less than 12ug/l) will be included in the study. All eligible women will be followed up at 22-23, 29-30 and 36-37 weeks' gestation for the change in hemoglobin level and ferritin level. all women will be also enquired about different side effects during treatment period.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 150 is above the median of 94 across 1,291 interventional studies indexed under Anemia.
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Exclusion Criteria:
this arm will contain 150 pregnant women with proved iron deficiency anemia and pregnant 14-18 weeks. these pregnant women will be given amino acid chelated iron capsules (15 mg iron/capsule) 1-2 capsules daily according to hemoglobin level (hemoglobin 7-9 g/dl will receive 2 capsules, and hemoglobin 9.1-11 g/dl will receive 1 capsule). complete blood picture and serum ferritin will be assessed at 22-23 weeks, 29-30 weeks and 36-37 weeks. possible side effects (colicky abdominal pains, constipation and metallic taste) will be asked about in each follow up visit.
Drug: amino acid chelated iron · Drug: iron salt (ferrous fumarate)
this arm will contain 150 pregnant women with proved iron deficiency anemia and 14-18 weeks gestation. these women will be given oral iron salt ferrous fumarate capsules (350 mg iron/ capsule containing about 70 mg elemental iron/ capsule) 1-2 capsules daily according to hemoglobin level (hemoglobin 7-9 g/dl will receive 2 capsules daily and hemoglobin 9.1-11 g/dl will receive 1 capsule daily. women will be followed up with complete blood picture and serum ferritin at 22-23 weeks, 29-30 weeks and 36-37 weeks. women will be asked about possible side effects (colicky abdominal pains, constipation, and metallic taste) in each visit.
Drug: amino acid chelated iron · Drug: iron salt (ferrous fumarate)
the drug will be given to pregnant women 14-18 weeks' gestation who prove to have iron deficiency anemia. the dose will be given according to hemoglobin level. for hemoglobin 7-9 g/dl, 2 capsules will be given daily. for hemoglobin 9.1-11 g/dl, 1 capsule will be given daily. complete blood picture and serum ferritin will be measured at 22-23, 29-30 and 36-37 weeks' gestation.
Also known as: ferrotron capsules
this drug will be given to pregnant women 14-18 weeks' gestation with iron deficiency anemia. the dose will be given according to hemoglobin level. for hemoglobin 7-9 g/dl, 2 capsules will be given daily, and for hemoglobin 9.1-11 g/dl, 1 capsule will be given daily. complete blood picture and serum ferritin will be measured at 22-23, 29-30 and 36-37 weeks' gestation.
Also known as: hemoton capsules
change in hemoglobin level
Time frame: 6 months
the occurence of side effects (abdominal colics, constipation, or metallic taste)
Time frame: 6 months
change in serum ferritin level
Time frame: 6 months
cost of treatment
Time frame: 6 months
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Cairo University