Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women

Anemia Clinical Trial

Official title:

Total Dose Infusion of Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212781
• Other study ID #: IDAO
• Status: Completed
• Phase: Phase 3
• First received: July 7, 2017
• Last updated: July 7, 2017
• Start date: June 2016
• Est. completion date: October 2016

Study information

• Verified date: July 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Iron deficiency is the most prevalent nutritional deficiency and the most common cause of anemia .It is characterized by a defect in hemoglobin synthesis, resulting in red blood cells that are abnormally small (microcytic) and contain a decreased amount of hemoglobin (hypochromic).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Hemoglobin < 10 g/dL

• Gestational age between 14-28 weeks.

• Willingness to participate and signing the informed consent form.

Exclusion Criteria:

• Iron overload or disturbances in utilization of iron

• Decompensated liver cirrhosis and active hepatitis

• Active acute or chronic infections

• History of multiple allergies

• Known hypersensitivity to parenteral iron or any recipients in the investigation drug products

• Erythropoietin treatment within 8 weeks prior to the screening visit

• Other iron treatment or blood transfusion within 4 weeks prior to the screening visit

• Planned elective surgery during the study.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency

Intervention

Drug:
• Iron dextran
total dose infusion
• Ferrous Fumarate
oral tablets

Locations

Country	Name	City	State
Egypt	Assiut Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in Hemoglobin concentration from baseline to 8 weeks therapy	measure hemoglobin level before and after treatment	8 weeks