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IRCT20251122068082N1 IRCT 2025-12-01 Jahrom University of Medical Sciences Effect of Different Oral Iron Dosing Regimens on Side Effects and Treatment Effectiveness in Iron Deficiency Anemia ida-iron "Effect of Daily, Alternate-Day, and Every-Other-Day Oral Iron Supplementation on Gastrointestinal Adverse Effects and Treatment Efficacy in Women Aged 18–45 with Iron Deficiency 2026-01-21 anticipated 80 Complete https://irct.ir/trial/87685 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be allocated to the study groups using variable block randomization based on a computer-generated random sequence. The unit of randomization is the individual eligible participant. To ensure balanced distribution of anemia severity between the groups, stratified randomization will be performed according to baseline hemoglobin levels in two strata (8 to <10 g/dL and 10 to 12 g/dL), with independent block randomization within each stratum. The random allocation sequence will be generated by an individual independent of the study team using statistical software, and variable block sizes will be applied without disclosure to investigators involved in participant enrollment. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes that will be opened only after eligibility has been confirmed for each participant. No quasi-random allocation methods will be used in this study, Blinding description: Double-blind Both participants and outcome assessors (clinical staff and data analysts) will remain unaware of group assignments. Blinding will be maintained using matched placebo tablets to ensure identical appearance and dosing schedule across all study arms. 4 iron deficiency anemia. Intervention 1: Intervention group: Participants in this group will receive oral iron supplementation in the form of ferrous sulfate tablets. Each tablet contains three hundred and twenty-five milligrams of ferrous sulfate equivalent to sixty-five milligrams of elemental iron. The tablets will be administered on an alternate-day regimen, with one tablet taken every other day, for a total duration of eight weeks. Tablets are to be taken preferably on an empty stomach with a glass of water. Intervention 2: Intervention group: Participants in this group will receive oral iron supplementation in the form of ferrous sulfate tablets. Each tablet contains three hundred and twenty-five milligrams of ferrous sulfate equivalent to sixty-five milligrams of elemental iron. The tablets will be administered every forty-eight hours, with one tablet taken once every forty-eight hours, for a total duration of eight weeks. Tablets are to be taken preferably on an empty stomach with a glass of water. Intervention 3: Control group: Participants in this group will receive oral iron supplementation in the form of ferrous sulfate tablets. Each tablet contains three hundred and twenty-five milligrams of ferrous sulfate equivalent to sixty-five milligrams of elemental iron. The tablets will be administered once daily, one tablet per day, for a total duration of eight weeks. Participants will be instructed to take the tablets preferably on an empty stomach with a glass of water. Yes - There is a plan to make this available What will be shared: The collected data in this study include de-identified participant information, laboratory test results, treatment adherence, and primary and secondary clinical outcomes. All data will be anonymized before sharing. The dataset includes all primary and secondary outcome measures, as well as details of interventions and study groups. When: Access to the data will be available starting six months after the publication of study results and will continue for five years thereafter. To whom: Active researchers at academic and scientific institutions can request access to the data. Independent researchers with a relevant research proposal and ethical approval may also be granted access. Conditions: Data are permitted solely for scientific research purposes, and commercial use is prohibited. Statistical analyses must follow the submitted research protocol, and any publication must cite the source and ethical approval. Where to obtain: Applicants can contact Dr. Hossein Ali Rostamipour at Imam Reza Clinic, adjacent to Peymanieh Hospital, Jahrom. Contact details: Phone: +989177911197, Email: hossainroscawi41@yahoo.com How to obtain: The applicant must complete and submit a formal request form, provide their research proposal, and ethical approval. After review by the study coordinator, approved data will be provided in a de-identified file. The process typically takes 2 to 4 weeks. Comments: All data and documents will be stored and shared in accordance with privacy regulations and research ethical standards.
public Hossein Ali Rostamipour
Motahari Blvd
Jahrom Iran (Islamic Republic of) 712346897 +98 71 5678 9456 hossainroscawi41@yahoo.com Jahrom University of Medical Sciences scientific Hossein Ali Rostamipour
motahari blvd
Jahrom Iran (Islamic Republic of) 7145673598 +98 71 5436 8345 hossainroscawi41@yahoo.com Jahrom University of Medical Sciences Iran (Islamic Republic of) Women aged 18 to 45 years attending the clinics of Jahrom University of Medical Sciences Diagnosis of iron deficiency anemia based on: Hemoglobin 8–12 g/dLSerum ferritin < 30 ng/mL No use of oral or injectable iron in the past 12 weeks (based on self-report and medical records) No history of surgery, chemotherapy, or blood donation in the past 12 weeks GFR > 30 mL/min No chronic inflammatory, renal, hepatic, or malignant disease No gastrointestinal disorders affecting iron absorption (e.g., celiac disease, Crohn’s disease, intestinal resection) No history of severe allergy or intolerance to iron supplements Ability to understand study information and provide informed consent 18 years 45 years Female Voluntary withdrawal by the participant at any time Pregnancy occurring during the study period Development of serious adverse events related to iron supplementation (e.g., severe allergic reaction or disabling gastrointestinal side effects) Non-adherence, defined as taking < 80% of the prescribed supplement Initiation or continuous use of interfering medications (e.g., antacids, proton pump inhibitors, or specific antibiotics) A final diagnosis other than iron deficiency anemia (e.g., anemia of chronic disease, thalassemia) Hospitalization or any clinical deterioration that prevents continuation of participation D50.9 Iron deficiency anemia, unspecified Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Participants in this group will receive oral iron supplementation in the form of ferrous sulfate tablets. Each tablet contains three hundred and twenty-five milligrams of ferrous sulfate equivalent to sixty-five milligrams of elemental iron. The tablets will be administered on an alternate-day regimen, with one tablet taken every other day, for a total duration of eight weeks. Tablets are to be taken preferably on an empty stomach with a glass of water. Intervention group: Participants in this group will receive oral iron supplementation in the form of ferrous sulfate tablets. Each tablet contains three hundred and twenty-five milligrams of ferrous sulfate equivalent to sixty-five milligrams of elemental iron. The tablets will be administered every forty-eight hours, with one tablet taken once every forty-eight hours, for a total duration of eight weeks. Tablets are to be taken preferably on an empty stomach with a glass of water. Control group: Participants in this group will receive oral iron supplementation in the form of ferrous sulfate tablets. Each tablet contains three hundred and twenty-five milligrams of ferrous sulfate equivalent to sixty-five milligrams of elemental iron. The tablets will be administered once daily, one tablet per day, for a total duration of eight weeks. Participants will be instructed to take the tablets preferably on an empty stomach with a glass of water. Change in Blood Hemoglobin Concentration. Timepoint: Measurement of blood hemoglobin concentration at baseline (before initiation of the intervention) and eight weeks after initiation of the intervention. Method of measurement: Measurement of blood hemoglobin concentration using peripheral blood sampling and analysis with an automated blood cell counter in a university-affiliated clinical laboratory. Severity of Gastrointestinal Adverse Effects Related to Iron Supplementation. Timepoint: Assessment of the severity of gastrointestinal adverse effects at baseline (before initiation of the intervention) and then weekly until the end of the eighth week of the intervention. Method of measurement: Assessment of the severity of gastrointestinal adverse effects including nausea, vomiting, abdominal pain, constipation, and diarrhea using a ten-point visual analogue scale completed by the participants. Adherence to Oral Iron Supplementation. Timepoint: Assessment of adherence to oral iron supplementation weekly during the intervention period and at the end of the eighth week. Method of measurement: Assessment of adherence to treatment based on pill count and participant self-report recorded in weekly follow-up forms. Change in Serum Ferritin Concentration. Timepoint: Measurement of serum ferritin concentration at baseline (before initiation of the intervention) and eight weeks after initiation of the intervention. Method of measurement: Measurement of serum ferritin concentration using blood samples and the immunoassay method in a university-affiliated clinical laboratory. Serum Hepcidin Level. Timepoint: Measurement of serum hepcidin level at baseline (before initiation of the intervention) and eight weeks after initiation of the intervention. Method of measurement: Measurement of serum hepcidin level using blood samples and the enzyme-linked immunosorbent assay (ELISA) method in a university-affiliated clinical laboratory. Jahrom University of Medical Sciences Approved 2025-11-12 Ethics committee of jahrom University of Medical Sciences motahari blvd jahrom Fars Iran (Islamic Republic of)