Optimizing Dosing Strategies in Oral Iron Supplementation

NCT06238895 | Completed Phase 4 DMC

• 1 other identifier: 2023-02317
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate, if a change in dosing strategy in oral iron supplementation from leads to an improvement of iron absorption and consequently a faster therapy in patients with iron deficiency. The main question the study aims to answer is: Does a treatment effect (measured by change in hemoglobin after 12 weeks of treatment) exist between daily oral iron supplementation and interval administration (every second day)? Participants will receive oral iron supplementation every second day with double the standard dose (intervention group). Researchers will compare this group with the active control group, that receives oral iron supplementation every day with the standard dose. Participants will present for three patient visits (at baseline, after 6 and after 12 weeks of treatment).

Conditions

Iron Deficiencies; Iron Deficiency Anemia; Iron Deficiency Anemia Treatment

Keywords

iron deficiency anemia; oral iron supplementation; iron supplementation; gender differences

Outcome Measures

Primary Outcomes (1)

• Change of Hemoglobin after 12 weeks

  Change (from baseline before treatment) of hemoglobin after 12 weeks of oral iron supplementation

  12 weeks

Secondary Outcomes (3)

• Proportion of participants achieving treatment goal

  12 weeks

• Change of iron parameters from baseline

  12 weeks

• Side effects

  12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Oral iron supplementation with Eisen-II-Sulfat (Tardyferon ®) Every second day 2 x 80 mg Tardyferon® for a duration of 12 weeks.

Drug: Tardyferon

Active Control

ACTIVE COMPARATOR

Oral iron supplementation with Eisen-II-Sulfat (Tardyferon ®) Every day 1x 80 mg Tardyferon® for a duration of 12 weeks

Drug: Tardyferon

Interventions

Tardyferon DRUG

Interval Dosing Strategy (Administration of oral iron every second day with double the standard dose instead of every day standard dose)

Active Control; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent signed by the subject
• ≥18 years of age
• Iron deficiency: Ferritin \<30 µg/l
• hemoglobin ≥ 80 g/l
• CRP \< 5 mg/l

You may not qualify if:

• Refusal of study participation,
• Regular administration of Erythropoietin
• Oral or intravenous iron supplementation \<12 weeks prior to investigation
• Contraindications to intervention medication (Tardyferon), e.g. known hypersensitivity or allergy to iron sulfate / ferrous sulfate
• Blood transfusion or donation \<12 weeks prior to investigation
• Active chemotherapy
• Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject.
• Note
• Anemia (as defined by the WHO): Hemoglobin \<130 g/L for men, Hemoglobin \<120 g/l for women, Hemoglobin \<110 g/l for pregnant women

Sponsors & Collaborators

• Luzerner Kantonsspital: lead

Study Sites (1)

Luzerner Kantonsspital

Lucerne, Switzerland

Location

MeSH Terms

Conditions

Iron Deficiencies; Anemia, Iron-Deficiency

Interventions

ferrous sulfate, mucin drug combination

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: March 1, 2024
• Primary Completion: November 18, 2025
• Study Completion: November 18, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)