Treatment of Iron Deficiency Anemia With Pregnancy

Early Phase 1CompletedNCT02005588

Cairo University150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Iron Deficiency Anemia of Pregnancy

Interventions

amino acid chelated ironDRUG

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)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.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

faculty of medicine, Cairo University

Cairo, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

change in hemoglobin level

Time frame: 6 months

Secondary Outcomes

the occurence of side effects (abdominal colics, constipation, or metallic taste)

Time frame: 6 months

change in serum ferritin level

Time frame: 6 months

Data from ClinicalTrials.gov

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