NCT03212781

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

3 months

First QC Date

July 7, 2017

Last Update Submit

July 7, 2017

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • The change in Hemoglobin concentration from baseline to 8 weeks therapy

    measure hemoglobin level before and after treatment

    8 weeks

Study Arms (2)

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

Iron dextranDRUG

total dose infusion

intravenous iron
Ferrous FumarateDRUG

oral tablets

oral iron

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Hemoglobin \< 10 g/dL
  • Gestational age between 14-28 weeks.
  • Willingness to participate and signing the informed consent form.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut Faculty of Medicine

Asyut, Egypt

Location

MeSH Terms

Conditions

Anemia

Interventions

Iron-Dextran Complexferrous fumarate

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 7, 2017

First Posted

July 11, 2017

Study Start

June 1, 2016

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

July 11, 2017

Record last verified: 2017-07

Locations

EG(1)