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OpenTrials
Completed

NCT Number: NCT06238895

Optimizing Dosing Strategies in Oral Iron Supplementation

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).

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Key information

Conditions

Iron Deficiencies Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiency Anemia Iron Deficiency Anemia Treatment Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Luzerner Kantonsspital

Lucerne, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Due to slow recruitment, the following inclusion criterion was removed on 09/25/2024 (MM/DD/YYYY):

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

Treatment and study plan

Tardyferon

Drug

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

Primary outcomes

  1. Change of Hemoglobin after 12 weeks

    Time frame: 12 weeks

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

Secondary outcomes

  1. Proportion of participants achieving treatment goal

    Time frame: 12 weeks

    Proportion of participants achieving either increase of hemoglobin (>20 g/l), normalization of hemoglobin (women >120 g/l, pregnant women >110 g/l and men >130 g/l) after 12 weeks of oral iron supplementation

  2. Change of iron parameters from baseline

    Time frame: 12 weeks

    Change of iron parameters from baseline compared to after treatment of 12 weeks

  3. Side effects

    Time frame: 12 weeks

    Side effects during treatment with oral iron supplementation in both groups (intervention and active control)

Sponsors and collaborators

Lead sponsor

Luzerner Kantonsspital

Other

Registry information

Acronym: OPTIDOSE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2024
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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