Iron Deficiency AnemiaPhase 4FER-IDIPNCT05278793
The Efficacy of Intermittent Versus Daily Oral Iron Supplementation in Anaemic Pregnant Women.
A Phase 4 study testing Ferrous fumarate in people with Iron Deficiency Anemia and Pregnancy Related, run by Martini Hospital Groningen at 1 site in Netherlands.
Trial summary
In this study intermittent dosage of iron supplementation three times a week will be compared to daily dosage in anaemic pregnant women due to iron deficiency. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia, Pregnancy Related
- What is being tested?
- Ferrous fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Jan 2022to Dec 2022
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women of 18 years and older
- Iron deficiency anaemia (defined as: Anaemia (haemoglobin lower than cut-off value) AND mean corpuscular volume (MCV) 70-85 fl OR ferritin <30ug/L) OR mean corpuscular volume (MCV) < 70fl / hemoglobinopathy is ruled out.
- Adequate mental health
- Good command of the Dutch language
- No participation in other research with medication
- Informed consent
Who cannot join
- Start of iron supplementation at pregnancy duration > 37 weeks (because of the limited time to achieve an increase in haemoglobin).
- History of bariatric surgery, inflammatory bowel disease, coeliac disease or Helicobacter pylori infection (because of malabsorption of iron).
- Patients who received blood transfusion or parental iron supplementation during the 3 months prior to screening (because of the effect on the haemoglobin level).
- Patients with significant bleeding, blood donation or surgery during pregnancy (because of the effect on the haemoglobin level).
- Allergy for iron.
- Anaemia of other cause, such as a hemoglobinopathy.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Martini Hospital Groningen
Groningen, 9728 NT
Maryse M de Graaf, drs, +31505246868, marysedegraaf@gmail.com
Janna JM Munster, dr, +31505245132, j.munster@mzh.nl
About this study
In this study intermittent dosage of iron supplementation three times a week will be compared to daily dosage in anaemic pregnant women due to iron deficiency.
Read the detailed description
Background of the study:
Iron deficiency anaemia in pregnancy is common and the standard treatment is iron supplementation once or twice daily. But there is no evidence for the optimal dose of iron supplementation in pregnancy. In non-pregnant women intermittent oral iron supplementation on alternate days is proven to have a similar effect on haemoglobin levels as iron supplementation daily with less side effects. In pregnancy the need and absorption of iron is physiologically higher. Therefore the optimal dose may differ from non-pregnant women.
The adverse effects of iron supplementation, which are mainly gastrointestinal effects, seem to be related to the dose of iron supplementation. These effects often already exist physiologically in pregnancy and may increase with the use of iron supplementation. Therefore, a lower dose would be preferable in pregnancy if the effectiveness is similar.
In this study intermittent dosage of iron supplementation three times a week will be compared to daily dosage in anaemic pregnant women due to iron deficiency. Our hypothesis is that intermittent oral iron supplementation is at least as effective as iron supplementation once daily and will give less adverse effects.
Objective of the study:
To compare the efficacy, side effects and therapy compliance of intermittent (three times a week) versus daily oral iron supplementation for anaemia in pregnancy attributed to iron deficiency.
Study design:
Single-centre, non-inferiority, open-label randomised controlled trial.
Study population:
Pregnant women of 18 years and older with iron deficiency anaemia.
Intervention:
One group will receive ferrous fumarate 200mg intermittent three times a week (for example on Monday, Wednesday and Friday) and one group will receive ferrous fumarate 200mg once daily.
Screening for anaemia during the pregnancy will be done according the local protocol in the first trimester and at a gestational age of 30 weeks. In women at risk for anaemia extra haemoglobin level will be measured at a gestational age of 20 weeks.
When a patient is eligible for the study she will be computer-randomised. Haemoglobin levels will be measured every 6 weeks after the start of the supplementation until the delivery. Side effects and therapy compliance will be evaluated with an interview.
Primary study parameters/outcome of the study:
The main endpoint of the study is the difference in haemoglobin level from baseline to 6 weeks as a continuous variable. A multivariate analysis will be performed with gestational age/trimester at start iron supplementation, the duration of the treatment, use of other supplements, vegetarian diet and the use of proton pump inhibitors or H2 receptor antagonists.
Secondary study parameters/outcome of the study:
The secondary endpoints are haemoglobin level at time of delivery, side effects, therapy compliance, term of delivery, birth weight, parenteral iron ante- or postpartum and blood transfusion postpartum.
- Conditions
- Iron Deficiency Anemia, Pregnancy Related
- Being tested
- Ferrous fumarate
- 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.
Ferrous fumarateDrug
Ferrous fumarate 200mg oral
| Study group | Role | What they receive |
|---|---|---|
| Intermittent | Experimental | This group will receive ferrous fumarate 200mg intermittent three times a week on alternate days. Receives: Drug: Ferrous fumarate |
| Daily | Active comparator | This group will receive ferrous fumarate 200mg once daily. Receives: Drug: Ferrous fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin level
The main endpoint of the study is the difference in haemoglobin level from baseline to 6 weeks as a continuous variable.
Measured: 6 weeks after start treatment
Secondary outcomes (7)
Side effects
The following treatment related adverse effects will be analysed: headache, dizziness, nausea, vomiting, constipation, diarrhoea. These known side effects of ferrous fumarate will be analysed with a written questionnaire.
Measured: 6 weeks after start treatment
Therapy compliance
Therapy compliance will be analysed with a validated questionnaire (SMAQ).The SMAQ was considered 'positive' when a non-adherent patient was detected, that is, when there was a positive response to any of the qualitative questions (question 1-3), more than two doses missed over the past week, or over 2 days of total non-medication during the past 3 months.
Measured: 6 weeks after start treatment
Haemoglobin level at time of delivery
When a subject is in labour a haemoglobin level will be measured.
Measured: At time of delivery
Term of delivery
Gestational age at delivery.
Measured: At delivery
Birth weight
The weight of the neonate.
Measured: At delivery
Parenteral iron ante- or postpartum
The need for parental iron supplementation when oral supplementation is not sufficient.
Measured: From start treatment until 1 week after delivery
Blood transfusion postpartum
The need for a blood transfusion postpartum because of anaemia as binary data (yes / no).
Measured: Until 1 week after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start7 Jan 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (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.
- 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
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martini Hospital Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- dr. J.M. Munster, gynaecologist, principal investigator
- Responsible party
- Principal investigator, Maryse de Graaf, Martini Hospital Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278793
- Sponsor's protocol ID
- NL77578.000.21
- Other IDs
- 2021-005393-26
- Acronym
- FER-IDIP
- Status last verified
- Mar 2022
- First submitted
- 15 Feb 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Intermittent Versus Daily Oral Iron Supplementation in Anaemic Pregnant Women.
- ClinicalTrials.gov ID
- NCT05278793
- Acronym / sponsor ID
- FER-IDIP / NL77578.000.21
- Conditions
- Iron Deficiency Anemia, Pregnancy Related
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Martini Hospital GroningenUniversity, hospital or other
- Collaborators
- dr. J.M. Munster, gynaecologist, principal investigator
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 14 Mar 2022 (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.
In this study intermittent dosage of iron supplementation three times a week will be compared to daily dosage in anaemic pregnant women due to iron deficiency.
Detailed description
Background of the study:
Iron deficiency anaemia in pregnancy is common and the standard treatment is iron supplementation once or twice daily. But there is no evidence for the optimal dose of iron supplementation in pregnancy. In non-pregnant women intermittent oral iron supplementation on alternate days is proven to have a similar effect on haemoglobin levels as iron supplementation daily with less side effects. In pregnancy the need and absorption of iron is physiologically higher. Therefore the optimal dose may differ from non-pregnant women.
The adverse effects of iron supplementation, which are mainly gastrointestinal effects, seem to be related to the dose of iron supplementation. These effects often already exist physiologically in pregnancy and may increase with the use of iron supplementation. Therefore, a lower dose would be preferable in pregnancy if the effectiveness is similar.
In this study intermittent dosage of iron supplementation three times a week will be compared to daily dosage in anaemic pregnant women due to iron deficiency. Our hypothesis is that intermittent oral iron supplementation is at least as effective as iron supplementation once daily and will give less adverse effects.
Objective of the study:
To compare the efficacy, side effects and therapy compliance of intermittent (three times a week) versus daily oral iron supplementation for anaemia in pregnancy attributed to iron deficiency.
Study design:
Single-centre, non-inferiority, open-label randomised controlled trial.
Study population:
Pregnant women of 18 years and older with iron deficiency anaemia.
Intervention:
One group will receive ferrous fumarate 200mg intermittent three times a week (for example on Monday, Wednesday and Friday) and one group will receive ferrous fumarate 200mg once daily.
Screening for anaemia during the pregnancy will be done according the local protocol in the first trimester and at a gestational age of 30 weeks. In women at risk for anaemia extra haemoglobin level will be measured at a gestational age of 20 weeks.
When a patient is eligible for the study she will be computer-randomised. Haemoglobin levels will be measured every 6 weeks after the start of the supplementation until the delivery. Side effects and therapy compliance will be evaluated with an interview.
Primary study parameters/outcome of the study:
The main endpoint of the study is the difference in haemoglobin level from baseline to 6 weeks as a continuous variable. A multivariate analysis will be performed with gestational age/trimester at start iron supplementation, the duration of the treatment, use of other supplements, vegetarian diet and the use of proton pump inhibitors or H2 receptor antagonists.
Secondary study parameters/outcome of the study:
The secondary endpoints are haemoglobin level at time of delivery, side effects, therapy compliance, term of delivery, birth weight, parenteral iron ante- or postpartum and blood transfusion postpartum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent | Experimental | Drug: Ferrous fumarateThis group will receive ferrous fumarate 200mg intermittent three times a week on alternate days. |
| Daily | Active comparator | Drug: Ferrous fumarateThis group will receive ferrous fumarate 200mg once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant women of 18 years and older
- Iron deficiency anaemia (defined as: Anaemia (haemoglobin lower than cut-off value) AND mean corpuscular volume (MCV) 70-85 fl OR ferritin <30ug/L) OR mean corpuscular volume (MCV) < 70fl / hemoglobinopathy is ruled out.
- Adequate mental health
- Good command of the Dutch language
- No participation in other research with medication
Key exclusion criteria (6 listed)
- Start of iron supplementation at pregnancy duration > 37 weeks (because of the limited time to achieve an increase in haemoglobin).
- History of bariatric surgery, inflammatory bowel disease, coeliac disease or Helicobacter pylori infection (because of malabsorption of iron).
- Patients who received blood transfusion or parental iron supplementation during the 3 months prior to screening (because of the effect on the haemoglobin level).
- Patients with significant bleeding, blood donation or surgery during pregnancy (because of the effect on the haemoglobin level).
- Allergy for iron.
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 |
|---|---|---|
| Ferrous fumarateFerrous fumarate 200mg oral | Drug | Daily, Intermittent |
Primary outcome
Haemoglobin level
Time frame: 6 weeks after start treatment
The main endpoint of the study is the difference in haemoglobin level from baseline to 6 weeks as a continuous variable.
7 secondary outcomes
Side effects
Time frame: 6 weeks after start treatment
Therapy compliance
Time frame: 6 weeks after start treatment
Haemoglobin level at time of delivery
Time frame: At time of delivery
Term of delivery
Time frame: At delivery
Birth weight
Time frame: At delivery
Parenteral iron ante- or postpartum
Time frame: From start treatment until 1 week after delivery
Blood transfusion postpartum
Time frame: Until 1 week after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: No
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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.
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 Ferrous fumarate in people with Iron Deficiency Anemia and Pregnancy Related, run by Martini Hospital Groningen at 1 site in Netherlands.
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 6 inclusion and 6 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 14 Mar 2022. 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 Netherlands. 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 Maryse M de Graaf, drs (+31505246868, marysedegraaf@gmail.come), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemoglobin level (time frame: 6 weeks after start treatment). 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 14 Mar 2022.