Treatment of Iron Deficiency Anemia With Pregnancy

NCT ID: NCT02005588

Last Updated: 2015-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-07-31

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.

Conditions

Iron Deficiency Anemia of Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

amino acid chelated iron arm

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.

Group Type: ACTIVE_COMPARATOR

amino acid chelated iron

Intervention Type: DRUG

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.

iron salt (ferrous fumarate)

Intervention Type: DRUG

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.

iron salt arm

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.

Group Type: ACTIVE_COMPARATOR

amino acid chelated iron

Intervention Type: DRUG

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.

iron salt (ferrous fumarate)

Intervention Type: DRUG

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.

Interventions

amino acid chelated iron

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.

Intervention Type: DRUG

iron salt (ferrous fumarate)

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.

Intervention Type: DRUG

Other Intervention Names

ferrotron capsules; hemoton capsules

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ghada Abdel Fattah

lecturer of obstetrics and gynecology, faculty of medicine, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed M Sayed, professor

Role: STUDY_DIRECTOR

Cairo University

Locations

faculty of medicine, Cairo University

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

nerhado pharmaceutical company

Identifier Type: REGISTRY

Identifier Source: secondary_id

ferrot2013

Identifier Type: -

Identifier Source: org_study_id