Iron Adverse ReactionIRONFITNCT07356258
Oral Iron in Pregnant Women: How Often to Take It and Its Side Effects and Tolerability
An observational study of Iron Adverse Reaction and Anemia Complicating Pregnancy, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
The goal of this prospective observational study is to examine the frequency of gastrointestinal side effects associated with oral iron supplementation during pregnancy. The main question it aims to answer is: Does intermittent oral iron supplementation result in fewer gastrointestinal side effects compared with daily… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Iron Adverse Reaction, Anemia Complicating Pregnancy
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2026to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women attending our high-risk pregnancy clinics (in Bnai Zion medical center)
Who may be able to join
- Pregnant women aged 18-50
- Indication for oral iron treatment as determined by the treating physician, in accordance with standard clinical practice
- Baseline iron store levels measured prior to initiation of oral iron therapy
Who cannot join
- Women taking ferrous sulfate 80 mg Tardiferon
- Gastrointestinal diseases such as colitis
- Women who received intravenous iron during pregnancy
- Women who received blood transfusions during pregnancy
- Women with anemia due to causes other than iron deficiency
- History of bariatric surgery
- Allergy to ferrous sulfate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Bnai Zion medical center
Haifa
Orna Caspin, +9725424444812, ornacaspin@gmail.com
Diana Shair Nakhleh, MD
About this study
Official title: Iron Supplementation Frequency and Tolerability in Pregnancy
The goal of this prospective observational study is to examine the frequency of gastrointestinal side effects associated with oral iron supplementation during pregnancy. The main question it aims to answer is:
Does intermittent oral iron supplementation result in fewer gastrointestinal side effects compared with daily supplementation in pregnant women? Pregnant women who are prescribed oral iron as part of their routine medical care will take ferrous sulfate on an alternate-day schedule for one week. If no significant gastrointestinal side effects are reported, they will then take ferrous sulfate daily for an additional week and will be followed for one month. Participants will be contacted by the study investigator to report gastrointestinal side effects, and routine blood tests will be used to assess changes in hemoglobin and iron stores.
Read the detailed description
This prospective observational study will be conducted in pregnant women who are prescribed oral iron supplementation as part of their routine prenatal care. The study is designed to reflect standard clinical practice and does not introduce any investigational treatment or deviation from accepted management.
Following enrollment, participants will receive oral ferrous sulfate in accordance with common clinical recommendations. The study includes two sequential exposure periods: an initial alternate-day dosing phase followed by a daily dosing phase, provided that no significant gastrointestinal intolerance is reported during the first phase.
At baseline, relevant demographic and pregnancy-related information will be recorded, including maternal age and gestational age at initiation of iron therapy. Baseline laboratory values related to iron status (including hemoglobin and iron stores) will be documented if obtained as part of routine care.
Participants will be instructed to take oral iron according to the prescribed schedule and to continue their usual diet and prenatal care. No dietary restrictions will be imposed as part of the study. Information regarding timing of iron intake, concomitant food consumption (including dairy products), and adherence will be collected through participant self-report.
Participants will be contacted by the study investigator at predefined time points during the supplementation period. Structured interviews will be used to assess gastrointestinal side effects, including constipation, abdominal pain, nausea, vomiting, diarrhea, bloating, and heartburn. Participants will be asked whether symptoms are new, worsened, or unchanged compared with baseline.
At one month after initiation of iron supplementation, participants will undergo follow-up blood tests as part of routine clinical monitoring to assess hemoglobin concentration and iron stores.
- Being tested
- No intervention. It's an observational study
- Keywords
- pregnancy, iron tolerability, oral iron supplementation, ron deficiency anemia, ferrous sulfate, alternate-day dosing, daily dosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. It's an observational studyOther
No intervention. It's an observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of gastrointestinal side effects in response to iron intake
Measured: Over the first 2 weeks of supplementation, with structured follow-up at week 1 and week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Adverse ReactionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356258
- Sponsor's protocol ID
- BNZ 013424
- Acronym
- IRONFIT
- Status last verified
- Dec 2025
- First submitted
- 11 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Supplementation Frequency and Tolerability in Pregnancy
- ClinicalTrials.gov ID
- NCT07356258
- Acronym / sponsor ID
- IRONFIT / BNZ 013424
- Keywords
- pregnancy, iron tolerability, oral iron supplementation, ron deficiency anemia, ferrous sulfate, alternate-day dosing, daily dosing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Jan 2026 (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.
The goal of this prospective observational study is to examine the frequency of gastrointestinal side effects associated with oral iron supplementation during pregnancy. The main question it aims to answer is:
Does intermittent oral iron supplementation result in fewer gastrointestinal side effects compared with daily supplementation in pregnant women? Pregnant women who are prescribed oral iron as part of their routine medical care will take ferrous sulfate on an alternate-day schedule for one week. If no significant gastrointestinal side effects are reported, they will then take ferrous sulfate daily for an additional week and will be followed for one month. Participants will be contacted by the study investigator to report gastrointestinal side effects, and routine blood tests will be used to assess changes in hemoglobin and iron stores.
Detailed description
This prospective observational study will be conducted in pregnant women who are prescribed oral iron supplementation as part of their routine prenatal care. The study is designed to reflect standard clinical practice and does not introduce any investigational treatment or deviation from accepted management.
Following enrollment, participants will receive oral ferrous sulfate in accordance with common clinical recommendations. The study includes two sequential exposure periods: an initial alternate-day dosing phase followed by a daily dosing phase, provided that no significant gastrointestinal intolerance is reported during the first phase.
At baseline, relevant demographic and pregnancy-related information will be recorded, including maternal age and gestational age at initiation of iron therapy. Baseline laboratory values related to iron status (including hemoglobin and iron stores) will be documented if obtained as part of routine care.
Participants will be instructed to take oral iron according to the prescribed schedule and to continue their usual diet and prenatal care. No dietary restrictions will be imposed as part of the study. Information regarding timing of iron intake, concomitant food consumption (including dairy products), and adherence will be collected through participant self-report.
Participants will be contacted by the study investigator at predefined time points during the supplementation period. Structured interviews will be used to assess gastrointestinal side effects, including constipation, abdominal pain, nausea, vomiting, diarrhea, bloating, and heartburn. Participants will be asked whether symptoms are new, worsened, or unchanged compared with baseline.
At one month after initiation of iron supplementation, participants will undergo follow-up blood tests as part of routine clinical monitoring to assess hemoglobin concentration and iron stores.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women attending our high-risk pregnancy clinics (in Bnai Zion medical center)
Key inclusion criteria (3 listed)
- Pregnant women aged 18-50
- Indication for oral iron treatment as determined by the treating physician, in accordance with standard clinical practice
- Baseline iron store levels measured prior to initiation of oral iron therapy
Key exclusion criteria (7 listed)
- Women taking ferrous sulfate 80 mg Tardiferon
- Gastrointestinal diseases such as colitis
- Women who received intravenous iron during pregnancy
- Women who received blood transfusions during pregnancy
- Women with anemia due to causes other than iron deficiency
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 |
|---|---|---|
| No intervention. It's an observational studyNo intervention. It's an observational study | Other | – |
Primary outcome
Incidence of gastrointestinal side effects in response to iron intake
Time frame: Over the first 2 weeks of supplementation, with structured follow-up at week 1 and week 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Iron Adverse Reaction
Not yet recruitingPhase 3
Comparison of Ferrous Salt vs. Liposomal Iron in Adult Women With Iron-Deficiency Anemia
Iron-deficiency Anemia (IDA), Hemoglobin
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Adverse Reaction and Anemia Complicating Pregnancy, run by Bnai Zion Medical Center at 1 site in Israel.
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 7 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: opening soon, as of the sponsor's last update on 27 Jan 2026. 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 Israel. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Shair Nakhleh, MD (+972549718833, shairdiana@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of gastrointestinal side effects in response to iron intake (time frame: Over the first 2 weeks of supplementation, with structured follow-up at week 1 and week 2). 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 27 Jan 2026.