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Effect of Different Oral Iron Dosing Regimens on Side Effects and Treatment Effectiveness in Iron Deficiency Anemia

"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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251122068082N1
Enrollment
80
Registered
2025-12-01
Start date
2026-01-21
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

iron deficiency anemia. Iron deficiency anemia, unspecified

Interventions

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 milligr

Sponsors

Jahrom University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 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 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Ali Rostamipour

Jahrom University of Medical Sciences

hossainroscawi41@yahoo.com+98 71 5678 9456

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026