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Completed

NCT Number: NCT05105438

Alternate Day vs. Daily Iron Supplementation in Iron Depleted Women

Iron deficiency (ID) with or without anemia is a major public health problem worldwide, especially in women of reproductive age. Iron supplementation can be an effective strategy to prevent and treat ID and iron deficiency anemia (IDA). Recent studies suggests that giving oral iron every other day would be an optimized dosing regimen with maximized absorption and a lower incidence of gastrointestinal side effects compared to consecutive day dosing. Long-term trials in which participants and investigators are blinded to the dosing interval with iron status and gastrointestinal side effects as study outcomes are needed.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ETH Zurich; Human Nutrition Laboratory; Institute of Food, Nutrition and Health

Zurich, 8092, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female, 18 to 45 years old,
  • SF levels <25 μg/L,
  • Hb levels ≥ 11 g/dL
  • Normal Body Mass Index (18.5-25 kg/m2),
  • In possession of a mobile phone on which the study app can be loaded,
  • Signed informed consent,
  • Not mandatory (only for subgroup analysis): having participated in a former stable iron isotope study in our laboratory between 1-5 y ago

Exclusion criteria

  • Elevated CRP > 5 mg/L,
  • Any metabolic, gastrointestinal, kidney or chronic disease (self-reported) affecting iron metabolism,
  • Continuous/long-term use of medication, which may interfere with iron absorption, gut physiology and iron metabolism,
  • Consumption of additional iron supplements over the study period,
  • Consumption of iron supplements since screening,
  • Difficulties with blood sampling,
  • Known hypersensitivity or allergy to iron or placebo capsules in the given amount (ferrous sulfate, mannitol, silica)
  • Pregnancy, breastfeeding
  • Women who intend to become pregnant during the course of the study,
  • Known or suspected non-compliance, drug or alcohol (more than 2 drinks/day) abuse,
  • Smokers (> 1 cigarette per week),
  • Participant is likely to be absent on one the study appointments,
  • Inability to follow the procedures of the study, e.g. due to language problems, self-reported psychological disorders, etc. of the participant.

Treatment and study plan

Consecutive Day Dosing

Dietary Supplement

100 mg iron as FeSO4 daily for 3 months, followed by matched placebo daily for 3 months.

Alternate Day Dosing

Dietary Supplement

100 mg iron as FeSO4 and matched placebo on alternating days for 6 months.

Primary outcomes

  1. Serum Ferritin (SF)

    Time frame: Day 93

    in consecutive day group

  2. Serum Ferritin (SF)

    Time frame: Day 186

    in alternate day group

  3. Event rate of GI side effects

    Time frame: Day 90

    in consecutive day group

  4. Event rate of GI side effects

    Time frame: Day 183

    in alternate day group

Secondary outcomes

  1. Hemoglobin (Hb)

    Time frame: Day 0

  2. Hemoglobin (Hb)

    Time frame: Day 46

  3. Hemoglobin (Hb)

    Time frame: Day 90

  4. Hemoglobin (Hb)

    Time frame: Day 139

  5. Hemoglobin (Hb)

    Time frame: Day 183

  6. Serum Ferritin (SF)

    Time frame: Day 0

  7. Serum Ferritin (SF)

    Time frame: Day 46

  8. Serum Ferritin (SF)

    Time frame: Day 93

  9. Serum Ferritin (SF)

    Time frame: Day 139

  10. Serum Ferritin (SF)

    Time frame: Day 186

  11. Serum Transferrin Receptor (sTfR)

    Time frame: Day 0

  12. Serum Transferrin Receptor (sTfR)

    Time frame: Day 46

  13. Serum Transferrin Receptor (sTfR)

    Time frame: Day 93

  14. Serum Transferrin Receptor (sTfR)

    Time frame: Day 139

  15. Serum Transferrin Receptor (sTfR)

    Time frame: Day 186

  16. Total iron binding capacity (TIBC)

    Time frame: Day 0

  17. Total iron binding capacity (TIBC)

    Time frame: Day 93

  18. Total iron binding capacity (TIBC)

    Time frame: Day 186

  19. Serum Iron (SFe)

    Time frame: Day 0

  20. Serum Iron (SFe)

    Time frame: Day 93

  21. Serum Iron (SFe)

    Time frame: Day 186

  22. C-Reactive Protein (CRP)

    Time frame: Day 0

  23. C-Reactive Protein (CRP)

    Time frame: Day 46

  24. C-Reactive Protein (CRP)

    Time frame: Day 93

  25. C-Reactive Protein (CRP)

    Time frame: Day 139

  26. C-Reactive Protein (CRP)

    Time frame: Day 186

  27. Alpha-1-acid Glycoprotein (AGP)

    Time frame: Day 0

  28. Alpha-1-acid Glycoprotein (AGP)

    Time frame: Day 46

  29. Alpha-1-acid Glycoprotein (AGP)

    Time frame: Day 93

  30. Alpha-1-acid Glycoprotein (AGP)

    Time frame: Day 139

  31. Alpha-1-acid Glycoprotein (AGP)

    Time frame: Day 186

  32. Intestinal Fatty Acid-binding Protein (I-FABP)

    Time frame: Day 0

  33. Intestinal Fatty Acid-binding Protein (I-FABP)

    Time frame: Day 90

  34. Intestinal Fatty Acid-binding Protein (I-FABP)

    Time frame: Day 183

  35. Calprotectin

    Time frame: Day 0

  36. Calprotectin

    Time frame: Day 90

  37. Calprotectin

    Time frame: Day 183

  38. Hepcidin

    Time frame: Day 0

  39. Hepcidin

    Time frame: Day 46

  40. Hepcidin

    Time frame: Day 90

  41. Hepcidin

    Time frame: Day 139

  42. Hepcidin

    Time frame: Day 183

  43. Event rate of GI side effects

    Time frame: Day 90

  44. Event rate of GI side effects

    Time frame: Day 183

  45. Incidence of GI side effects

    Time frame: Day 90

  46. Incidence of GI side effects

    Time frame: Day 183

  47. Event proportion of GI side effects

    Time frame: Day 90

  48. Event proportion of GI side effects

    Time frame: Day 183

  49. Severity of GI side effects

    Time frame: Day 90

  50. Severity of GI side effects

    Time frame: Day 183

  51. Fecal blood losses

    Time frame: Day 0

  52. Fecal blood losses

    Time frame: Day 90

  53. Fecal blood losses

    Time frame: Day 183

  54. Iron absorption from supplements

    Time frame: Day 90

  55. Iron absorption from supplements

    Time frame: Day 183

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Registry information

Official study title

Comparing Oral Iron Supplementation Using Alternate-day Dosing to the Standard of Care Consecutive-day Dosing in Iron-depleted Women With or Without Mild Anemia

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 3, 2021
Registry last updated
Jan 24, 2024

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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