Iron Dextran Versus Oral Iron for Treating Iron Deficienc... | NCT03212781

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

NCT03212781

Sponsor

Assiut University

Status

Completed

Last Update Posted

Jul 11, 2017Actual

Enrollment

66Actual

Phase

Phase 3

Conditions

Anemia

Interventions

Iron dextran
Ferrous Fumarate

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016Actual

Primary Completion Date

Sep 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Jul 7, 2017

First Submission Date that Met QC Criteria

Jul 7, 2017

First Posted Date

Jul 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2017

Last Update Posted Date

Jul 11, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intravenous iron	Experimental	patients will receive intravenous iron as total dose infusion	Drug: Iron dextran
oral iron	Active Comparator	patients will receive oral iron	Drug: Ferrous Fumarate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iron dextran	Drug	total dose infusion	intravenous iron
Ferrous Fumarate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change in Hemoglobin concentration from baseline to 8 weeks therapy	measure hemoglobin level before and after treatment	8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut Faculty of Medicine		Asyut			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D000740	Anemia

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007505	Iron-Dextran Complex
C031621	ferrous fumarate

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D003911	Dextrans
D005936	Glucans

Browse Leaves

Not provided

Browse Branches

Not provided