Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-01 @ 6:37 PM
Study NCT ID:
NCT07356258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-27
First Post:
2026-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Iron in Pregnant Women: How Often to Take It and Its Side Effects and Tolerability
Sponsor:
Bnai Zion Medical Center
Organization:
Study Overview
Official Title:
Iron Supplementation Frequency and Tolerability in Pregnancy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IRONFIT
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: