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

NCT ID: NCT03212781

Last Updated: 2017-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intravenous iron

patients will receive intravenous iron as total dose infusion

Group Type EXPERIMENTAL

Iron dextran

Intervention Type DRUG

total dose infusion

oral iron

patients will receive oral iron

Group Type ACTIVE_COMPARATOR

Ferrous Fumarate

Intervention Type DRUG

oral tablets

Interventions

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Iron dextran

total dose infusion

Intervention Type DRUG

Ferrous Fumarate

oral tablets

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut Faculty of Medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IDAO

Identifier Type: -

Identifier Source: org_study_id

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