AnemiaPhase 4EIVFNCT00746551
Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment
A Phase 4 study testing Ferli-6® (Continental Pharm co., ltd.) and Venofer® (Vifor AG, St. Gallen, Switzerland) in people with Anemia and Pregnancy Complications, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to compare the efficacy of body iron storage replenishment between low dose intravenous iron and oral iron in late pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia, Pregnancy Complications
- What is being tested?
- Ferli-6® (Continental Pharm co., ltd.) and Venofer® (Vifor AG, St. Gallen, Switzerland)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2008to Apr 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-45 years old
- Singleton pregnancy at 32 weeks gestation
- Having anemia in the third trimester according to World Health Organization, namely, with a hemoglobin level of < 11 g/dL or hematocrit of < 33%
- Having no underlying disease such as hypertension, gestational diabetes mellitus, heart disease, peptic ulcer, etc.
- Having no history of allergy to iron containing medication
- Having no history or other allergic conditions or asthma
Show all 11Show fewer
- Having no thalassemia disease, for examples: B thalassemia major, hemoglobin E/ B thalassemia, homozygous hemoglobin E, Hemoglobin H, AE Bart disease, and EF Bart disease. Pregnant women who have iron deficiency anemia and are thalassemia carriers such as A-thalassemia 1, B-thalassemia, or less severe Hb E/ B thalassemia are able to enter the study.
- Having no history of bleeding tendency
- Having no history of blood transfusion within the prior 120 days
- Having no history of delivery before 36 weeks gestation
- Giving consent and having signed the consent form for this study
Who cannot join
- Stool exam revealed parasitic infestation
- C-reactive protein > 3 mg/L
- Serum ferritin > 15 mcg/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Dose Intravenous Versus Oral Iron for Iron Deficiency Anemia Starting Late in Pregnancy: A Randomized Controlled Trial
The purpose of this study is to compare the efficacy of body iron storage replenishment between low dose intravenous iron and oral iron in late pregnancy.
Read the detailed description
Despite routine antenatal oral iron supplementation, the prevalence of iron deficiency anemia (IDA) in the 3rd trimester of pregnancy in developing countries remains high. Apparently, intravenous iron sucrose appears to be safe and efficient in treating within a short period. From literature review, no study of intravenous iron for IDA treatment has been carried out in the third trimester of pregnancy. This research aims to compare the efficacy of body iron storage replenishment at 3 weeks as labor may take place at this point in some women. In this study,500 mg intravenous iron has been given weekly instead of every other day for the sake of patient's convenience in the hope that parenteral iron may become another alternative for treatment of pregnant women with iron deficiency anemia who have difficulties or failures with oral iron.
- Conditions
- Anemia, Pregnancy Complications
- Being tested
- Ferli-6® (Continental Pharm co., ltd.), Venofer® (Vifor AG, St. Gallen, Switzerland)
- Keywords
- iron deficiency anemia, pregnancy, third trimester, intravenous iron, efficacy, a randomized trial, Female, Ferric Compounds/therapeutic use*, Infusions, Intravenous, Hematologic/therapy*
- Medical subject headings
- Anemia, Pregnancy Complications, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferli-6® (Continental Pharm co., ltd.)Drug
In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out.
Venofer® (Vifor AG, St. Gallen, Switzerland)Drug
Women in the IV-group received 500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland) divided into three weekly administrations. Two doses of 200 mg iron sucrose were given at 33 and 34 weeks gestation while the remaining (100 mg) was infused at gestation of 35 weeks. Thereafter, women in this group received no further iron therapy until delivery. In preparation, 200 mg of iron sucrose was diluted into 100 ml of 0.9% saline solution.
| Study group | Role | What they receive |
|---|---|---|
| Ferrous fumarate, Ferri-6®, Oral tablet | Active comparator | In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out. Receives: Drug: Ferli-6® (Continental Pharm co., ltd.) |
| iron sucrose, Venofer®, intravenous drug | Experimental | Women in the IV-group received 500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland) divided into three weekly administrations. Two doses of 200 mg iron sucrose were given at 33 and 34 weeks gestation while the remaining (100 mg) was infused at gestation of 35 weeks. Thereafter, women in this group received no further iron therapy until delivery. In preparation, 200 mg of iron sucrose was diluted into 100 ml of 0.9% saline solution. Receives: Drug: Venofer® (Vifor AG, St. Gallen, Switzerland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Ferritin Level
Measured: 3 weeks after intervention
Secondary outcomes (1)
Haemoglobin Level
Measured: 3 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionMar 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Mahidol 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma
- Responsible party
- Principal investigator, Pharuhas Chanprapaph, Mahidol University
- Investigators
- Pornpimol Ruangvutilert, MD, PhD., Principal investigator, Obstetrics and Gynecology Department, Faculty of Medicine Siriraj Hosptial, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746551
- Sponsor's protocol ID
- 296/2551(EC3)
- Acronym
- EIVF
- Status last verified
- Feb 2015
- First submitted
- 2 Sep 2008
- Last updated
- 16 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Intravenous Versus Oral Iron for Iron Deficiency Anemia Starting Late in Pregnancy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00746551
- Acronym / sponsor ID
- EIVF / 296/2551(EC3)
- Conditions
- Anemia, Pregnancy Complications
- Keywords
- iron deficiency anemia, pregnancy, third trimester, intravenous iron, efficacy, a randomized trial, Female, Ferric Compounds/therapeutic use*
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Vifor Pharma
- Study start
- Sep 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 4 Sep 2008 (estimated)
- Results
- Posted 16 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy of body iron storage replenishment between low dose intravenous iron and oral iron in late pregnancy.
Detailed description
Despite routine antenatal oral iron supplementation, the prevalence of iron deficiency anemia (IDA) in the 3rd trimester of pregnancy in developing countries remains high. Apparently, intravenous iron sucrose appears to be safe and efficient in treating within a short period. From literature review, no study of intravenous iron for IDA treatment has been carried out in the third trimester of pregnancy. This research aims to compare the efficacy of body iron storage replenishment at 3 weeks as labor may take place at this point in some women. In this study,500 mg intravenous iron has been given weekly instead of every other day for the sake of patient's convenience in the hope that parenteral iron may become another alternative for treatment of pregnant women with iron deficiency anemia who have difficulties or failures with oral iron.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferrous fumarate, Ferri-6®, Oral tablet | Active comparator | Drug: Ferli-6® (Continental Pharm co., ltd.)In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out. |
| iron sucrose, Venofer®, intravenous drug | Experimental | Drug: Venofer® (Vifor AG, St. Gallen, Switzerland)Women in the IV-group received 500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland) divided into three weekly administrations. Two doses of 200 mg iron sucrose were given at 33 and 34 weeks gestation while the remaining (100 mg) was infused at gestation of 35 weeks. Thereafter, women in this group received no further iron therapy until delivery. In preparation, 200 mg of iron sucrose was diluted into 100 ml of 0.9% saline solution. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age 18-45 years old
- Singleton pregnancy at 32 weeks gestation
- Having anemia in the third trimester according to World Health Organization, namely, with a hemoglobin level of < 11 g/dL or hematocrit of < 33%
- Having no underlying disease such as hypertension, gestational diabetes mellitus, heart disease, peptic ulcer, etc.
- Having no history of allergy to iron containing medication
Key exclusion criteria (3 listed)
- Stool exam revealed parasitic infestation
- C-reactive protein > 3 mg/L
- Serum ferritin > 15 mcg/L
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 |
|---|---|---|
| Ferli-6® (Continental Pharm co., ltd.)In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out. | Drug | Ferrous fumarate, Ferri-6®, Oral tablet |
| Venofer® (Vifor AG, St. Gallen, Switzerland)Women in the IV-group received 500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland) divided into three weekly administrations. Two doses of 200 mg iron sucrose were given at 33 and 34 weeks gestation while the remaining (100 mg) was infused at gestation of 35 weeks. Thereafter, women in this group received no further iron therapy until delivery. In preparation, 200 mg of iron sucrose was diluted into 100 ml of 0.9% saline solution. | Drug | iron sucrose, Venofer®, intravenous drug |
Primary outcome
Serum Ferritin Level
Time frame: 3 weeks after intervention
1 secondary outcome
Haemoglobin Level
Time frame: 3 weeks after intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Pornpimol Ruangvutilert, MD, PhD. principal investigator
Obstetrics and Gynecology Department, Faculty of Medicine Siriraj Hosptial, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferli-6® (Continental Pharm co., ltd.) and Venofer® (Vifor AG, St. Gallen, Switzerland) in people with Anemia and Pregnancy Complications, run by Mahidol University at 1 site in Thailand.
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 11 inclusion and 3 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 16 Feb 2015. 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 Thailand. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serum Ferritin Level (time frame: 3 weeks after intervention). 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 16 Feb 2015.