AnemiaPhase 3NCT03212781
Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women
A Phase 3 study testing Iron dextran and Ferrous Fumarate in people with Anemia, run by Assiut University at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anemia
- What is being tested?
- Iron dextran and Ferrous Fumarate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2016to Oct 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Hemoglobin < 10 g/dL
- Gestational age between 14-28 weeks.
- Willingness to participate and signing the informed consent form.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Total Dose Infusion of Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women: a Randomized Controlled Trial
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).
- Conditions
- Anemia
- Being tested
- Iron dextran, Ferrous Fumarate
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron dextranDrug
total dose infusion
Ferrous FumarateDrug
oral tablets
| Study group | Role | What they receive |
|---|---|---|
| intravenous iron | Experimental | patients will receive intravenous iron as total dose infusion Receives: Drug: Iron dextran |
| oral iron | Active comparator | patients will receive oral iron Receives: Drug: Ferrous Fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Hemoglobin concentration from baseline to 8 weeks therapy
measure hemoglobin level before and after treatment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study startJun 2016
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212781
- Sponsor's protocol ID
- IDAO
- Status last verified
- Jul 2017
- First submitted
- 7 Jul 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Dose Infusion of Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03212781
- Acronym / sponsor ID
- IDAO
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous iron | Experimental | Drug: Iron dextranpatients will receive intravenous iron as total dose infusion |
| oral iron | Active comparator | Drug: Ferrous Fumaratepatients will receive oral iron |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Hemoglobin < 10 g/dL
- Gestational age between 14-28 weeks.
- Willingness to participate and signing the informed consent form.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron dextrantotal dose infusion | Drug | intravenous iron |
| Ferrous Fumarateoral tablets | Drug | oral iron |
Primary outcome
The change in Hemoglobin concentration from baseline to 8 weeks therapy
Time frame: 8 weeks
measure hemoglobin level before and after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iron dextran and Ferrous Fumarate in people with Anemia, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in Hemoglobin concentration from baseline to 8 weeks therapy (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.