Iron-Deficiency AnemiaPhase 4EDISANCT02487719
Different Iron Supplements for Prevention of Anemia in Pregnancy
A Phase 4 study testing Iron sulfate and Iron polymaltose for prevention of iron deficiency anemia in people with Iron-Deficiency Anemia and Pregnancy, run by University of Zurich at 1 site in Switzerland.
Trial summary
Examination of iron supplements routinely used in pregnancy to compare these with one another regarding effectiveness in the prevention of iron deficiency. Determination of ferritin / hemoglobin every pregnant woman under the first routine check. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-Deficiency Anemia, Pregnancy
- What is being tested?
- Iron sulfate and Iron polymaltose for prevention of iron deficiency anemia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2015to Aug 2016
- Phase
- Phase 4
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age above 18 yrs, singelton rpegnancy, inclusion before 16 completed weeks of gestation
Who cannot join
- multiple pregnancy, contraindication for oral iron supplements or mulltivitamin preparations
- iron deficiency or other anemia
- hemoglobinopatheis
- clinically significant disorders, as renal insuffisciency, hepatic dysfunction, cardiovascular disease
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Dept of Obstetrics
Zurich, Canton of Zurich, 8091
ALexander Krafft, MD, +41442551111, alexander.krafft@usz.ch
Michele Stahel, MD, +41442551111, michele.stahel@usz.ch
About this study
Official title: Effektivität Der in Der Schwangerschaftsvorsorge routinemässig Angewandten Eisenprophylaxe
Examination of iron supplements routinely used in pregnancy to compare these with one another regarding effectiveness in the prevention of iron deficiency.
Determination of ferritin / hemoglobin every pregnant woman under the first routine check. Classification into one of three subgroups (group 1: iron sulfate, Group 2: iron polymaltose, Group 3: multivitamin- multimineral) depending on the measured values. Repetition of hemoglobin every 8 weeks, at the entrance to birth and postpartum day 1, additional provision of ferritin at the entrance to birth. In addition, registration of each child's birth weight and gestational age.
Read the detailed description
Worldwide, iron deficiency is the most common shortage in women of childbearing age and also the most common cause of anemia. The prevalence of iron deficiency in young not pregnant women is 10-30%. During pregnancy take Frequency and importance of iron deficiency. Through organic growth and development of fetoplacental Unit and by maternal tissue formation, uterus growth and strong Expansion of maternal blood volume increases the pregnant woman the iron requirement for a Multiple. Starting from a non-pregnant state in the daily requirement of about 1 mg increasing this to 4-5 mg. Even with optimum food selection and a secured Increase of intestinal absorption in pregnancy, there is a negative Iron balance. The consequences are a depletion of iron stores (Serum ferritin <15 mcg / L) and a qualitative and quantitative disturbance of maternal Erythropoiesis with increased hypochromic and microcytic erythrocytes up to the occurrence anemia. The increased iron requirement is the background to a general recommendation an iron prophylaxis during pregnancy. However, this is possible due Reinforcement of gastrointestinal symptoms usually only from the 12th week of pregnancy is recommended. All pregnant women receive from the 12th week of pregnancy a multivitamin supplementation for the most important trace elements and vitamins. According to the guidelines of the Department of Obstetrics of USZ should a pregnant woman after the 12th week of pregnancy at a marginal ferritin <50mcg / l prophylactically receive additional iron and so anemia can be prevented. The aim of the study is on the one hand today's conventional iron supplements Maltofer Fol and Gyno-Tardyferon to examine their effectiveness, in particular with regard to the difference between two- and trivalent iron. On the other hand are at the usual multivitamin supplements. Women with normal iron stores at the beginning with respect to their effectiveness in preventing a depletion of these stores will be examined. Another aspect to be examined the occurrence of manifest iron deficiency anemia among called iron prophylaxis.
According to ferrtin value at first pregancy check, patients are enrolled after informed consent.
ferritin >50 mcg/L means patient will be randomized in eiter iron sulfate or iron polymaltose group. Ferritin > 50 mcg/L means pt will reeive multivitamin - multimineral containing iron. At midpregancy ferritin value is routinely checked as well at entering delivery floor at term.
- Conditions
- Iron-Deficiency Anemia, Pregnancy
- Being tested
- Iron sulfate and Iron polymaltose for prevention of iron deficiency anemia
- Keywords
- Iron deficiecy, pregnancy, prenatal care
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron sulfate and Iron polymaltose for prevention of iron deficiency anemiaDrug
Also called gynotardiferon, maltofer, elevit
| Study group | Role | What they receive |
|---|---|---|
| Iron sulfate | Active comparator | Iron sulfate (or) is given if randomly asigned in this group and Ferritin at inclusion < 50 mcg/L.
intervention: oral iron sulfate 1 tbl daily until birth Receives: Drug: Iron sulfate and Iron polymaltose for prevention of iron deficiency anemia |
| Iron polymaltose | Active comparator | Iron polymaltose (or) is given if randomly asigned in this group and Ferritin at inclusion < 50 mcg/L.
intervention: oral iron polymaltose 1 tbl daily until birth Receives: Drug: Iron sulfate and Iron polymaltose for prevention of iron deficiency anemia |
| Multimineral | No intervention | Routine supplementation of multivitamin. multimineral only. Ferritin level > 50 mcg/L at inclusion. No additional iron supplementation. oral multivitamin- multimineral preparation 1 tbl daily until birth as done in daily clinic routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin before delivery
anemia prevalence at delivery
Measured: up to 32 weeks
Secondary outcomes (4)
Birthweight
birthweight at term
Measured: measured once at birth
Gestatonal age at birth
percentage of preterm delivies in each arm
Measured: measured once at birth
Discontinuation of iron or mulimineral supplementation
discontinuation rate in every arm
Measured: delivery
Ferritin before delivery
body iron stores at delivery
Measured: up to 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Krafft, MD, Principal investigator, University Hospital Zurich, Div. of Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487719
- Sponsor's protocol ID
- 2012-0475
- Acronym
- EDISA
- Status last verified
- Jun 2015
- First submitted
- 9 Jun 2015
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effektivität Der in Der Schwangerschaftsvorsorge routinemässig Angewandten Eisenprophylaxe
- ClinicalTrials.gov ID
- NCT02487719
- Acronym / sponsor ID
- EDISA / 2012-0475
- Conditions
- Iron-Deficiency Anemia, Pregnancy
- Keywords
- Iron deficiecy, pregnancy, prenatal care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 1 Jul 2015 (estimated)
- 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.
Examination of iron supplements routinely used in pregnancy to compare these with one another regarding effectiveness in the prevention of iron deficiency.
Determination of ferritin / hemoglobin every pregnant woman under the first routine check. Classification into one of three subgroups (group 1: iron sulfate, Group 2: iron polymaltose, Group 3: multivitamin- multimineral) depending on the measured values. Repetition of hemoglobin every 8 weeks, at the entrance to birth and postpartum day 1, additional provision of ferritin at the entrance to birth. In addition, registration of each child's birth weight and gestational age.
Detailed description
Worldwide, iron deficiency is the most common shortage in women of childbearing age and also the most common cause of anemia. The prevalence of iron deficiency in young not pregnant women is 10-30%. During pregnancy take Frequency and importance of iron deficiency. Through organic growth and development of fetoplacental Unit and by maternal tissue formation, uterus growth and strong Expansion of maternal blood volume increases the pregnant woman the iron requirement for a Multiple. Starting from a non-pregnant state in the daily requirement of about 1 mg increasing this to 4-5 mg. Even with optimum food selection and a secured Increase of intestinal absorption in pregnancy, there is a negative Iron balance. The consequences are a depletion of iron stores (Serum ferritin <15 mcg / L) and a qualitative and quantitative disturbance of maternal Erythropoiesis with increased hypochromic and microcytic erythrocytes up to the occurrence anemia. The increased iron requirement is the background to a general recommendation an iron prophylaxis during pregnancy. However, this is possible due Reinforcement of gastrointestinal symptoms usually only from the 12th week of pregnancy is recommended. All pregnant women receive from the 12th week of pregnancy a multivitamin supplementation for the most important trace elements and vitamins. According to the guidelines of the Department of Obstetrics of USZ should a pregnant woman after the 12th week of pregnancy at a marginal ferritin <50mcg / l prophylactically receive additional iron and so anemia can be prevented. The aim of the study is on the one hand today's conventional iron supplements Maltofer Fol and Gyno-Tardyferon to examine their effectiveness, in particular with regard to the difference between two- and trivalent iron. On the other hand are at the usual multivitamin supplements. Women with normal iron stores at the beginning with respect to their effectiveness in preventing a depletion of these stores will be examined. Another aspect to be examined the occurrence of manifest iron deficiency anemia among called iron prophylaxis.
According to ferrtin value at first pregancy check, patients are enrolled after informed consent.
ferritin >50 mcg/L means patient will be randomized in eiter iron sulfate or iron polymaltose group. Ferritin > 50 mcg/L means pt will reeive multivitamin - multimineral containing iron. At midpregancy ferritin value is routinely checked as well at entering delivery floor at term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Iron sulfate | Active comparator | Drug: Iron sulfate and Iron polymaltose for prevention of iron deficiency anemiaIron sulfate (or) is given if randomly asigned in this group and Ferritin at inclusion < 50 mcg/L. intervention: oral iron sulfate 1 tbl daily until birth |
| Iron polymaltose | Active comparator | Drug: Iron sulfate and Iron polymaltose for prevention of iron deficiency anemiaIron polymaltose (or) is given if randomly asigned in this group and Ferritin at inclusion < 50 mcg/L. intervention: oral iron polymaltose 1 tbl daily until birth |
| Multimineral | No intervention | –Routine supplementation of multivitamin. multimineral only. Ferritin level > 50 mcg/L at inclusion. No additional iron supplementation. oral multivitamin- multimineral preparation 1 tbl daily until birth as done in daily clinic routine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age above 18 yrs, singelton rpegnancy, inclusion before 16 completed weeks of gestation
Key exclusion criteria (4 listed)
- multiple pregnancy, contraindication for oral iron supplements or mulltivitamin preparations
- iron deficiency or other anemia
- hemoglobinopatheis
- clinically significant disorders, as renal insuffisciency, hepatic dysfunction, cardiovascular disease
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 sulfate and Iron polymaltose for prevention of iron deficiency anemiaAlso: gynotardiferon, maltofer, elevit | Drug | Iron polymaltose, Iron sulfate |
Primary outcome
Hemoglobin before delivery
Time frame: up to 32 weeks
anemia prevalence at delivery
4 secondary outcomes
Birthweight
Time frame: measured once at birth
Gestatonal age at birth
Time frame: measured once at birth
Discontinuation of iron or mulimineral supplementation
Time frame: delivery
Ferritin before delivery
Time frame: up to 32 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
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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.
Alexander Krafft, MD principal investigator
University Hospital Zurich, Div. of Obstetrics
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 Iron sulfate and Iron polymaltose for prevention of iron deficiency anemia in people with Iron-Deficiency Anemia and Pregnancy, run by University of Zurich at 1 site in Switzerland.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Jul 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Krafft, M.D (+41442551111, alexander.krafft@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin before delivery (time frame: up to 32 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 1 Jul 2015.