Oral Iron in Pregnant Women: How Often to Take It and Its Side Effects and Tolerability

NCT07356258 | Not Yet Recruiting

• 1 other identifier: BNZ 013424
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Iron Adverse Reaction; Anemia Complicating Pregnancy

Keywords

pregnancy; iron tolerability; oral iron supplementation; ron deficiency anemia; ferrous sulfate; alternate-day dosing; daily dosing

Outcome Measures

Primary Outcomes (1)

• Incidence of gastrointestinal side effects in response to iron intake

  Over the first 2 weeks of supplementation, with structured follow-up at week 1 and week 2

Interventions

No intervention. It's an observational study OTHER

No intervention. It's an observational study

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women attending our high-risk pregnancy clinics (in Bnai Zion medical center)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

Study Sites (1)

Bnai Zion medical center

Haifa, Israel

Location

Central Study Contacts

Diana Shair Nakhleh, MD

CONTACT

+972549718833; shairdiana@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 21, 2026
• Study Start: February 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)