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NCT Number: NCT02005588

Treatment of Iron Deficiency Anemia With Pregnancy

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

faculty of medicine, Cairo University

Cairo, Cairo Governorate, 002, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

amino acid chelated iron

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.

Other names: ferrotron capsules

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.

Other names: hemoton capsules

Primary outcomes

  1. change in hemoglobin level

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 months

  2. change in serum ferritin level

    Time frame: 6 months

Other outcomes

  1. cost of treatment

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 9, 2013
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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