Treatment of Iron Deficiency Anemia With Pregnancy

Early Phase 1

Completed

• Conditions: Iron Deficiency Anemia of Pregnancy
• Interventions: Drug: amino acid chelated iron; Drug: iron salt (ferrous fumarate)

• Registration Number: NCT02005588
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-11-27
• Study Start: 2013-12
• Study First Submitted QC: 2013-12-04
• Study First Posted: 2013-12-09
• Primary Completion: 2015-06
• Status Verified: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Age: 20-40 years
• Pregnant 14-18 weeks
• Singleton fetus
• Hb 7-10.9 g/dl
• Serum ferritin <12 microgram/L

Exclusion Criteria

• history of anemia due to other causes as chronic blood loss, hemolytic anemia or thalassemia
• Multiple pregnancy
• known hepatic, renal or cardiovascular abnormality.
• Known peptic ulcer, esophagitis, gastritis or hiatus hernia.
• Family history of thalassemia, sickle cell anemia, or malabsorption syndrome.
• Iron preparation intake within 24 hours of inclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
amino acid chelated iron arm	amino acid chelated iron	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.
amino acid chelated iron arm	iron salt (ferrous fumarate)	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.
iron salt arm	amino acid chelated iron	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.
iron salt arm	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.

Primary Outcome Measures

Name	Time	Method
change in hemoglobin level	6 months

Secondary Outcome Measures

Name	Time	Method
the occurence of side effects (abdominal colics, constipation, or metallic taste)	6 months
change in serum ferritin level	6 months

Trial Locations

Locations (1)

faculty of medicine, Cairo University; 🇪🇬 Cairo, Egypt