Treatment of Iron Deficiency Anemia With Pregnancy

Comparison Between Aminoacid Chelated Iron and Iron Salt in Treatment of Iron Deficiency Anemia With Pregnancy

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02005588

Enrollment

150

Registered

2013-12-09

Start date

2013-12-31

Completion date

2015-07-31

Last updated

2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia of Pregnancy

Keywords

amino acid chelated iron, iron salt, iron deficiency anemia

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.

Interventions

DRUGamino 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.

DRUGiron 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
change in hemoglobin level	6 months

Secondary

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

Other

Measure	Time frame
cost of treatment	6 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026