AzTrials
AzTrials

Iron-deficiencyNCT05105438

Alternate Day vs. Daily Iron Supplementation in Iron Depleted Women

A study testing Consecutive Day Dosing and Alternate Day Dosing in people with Iron-deficiency and Iron Deficiency Anemia, run by Swiss Federal Institute of Technology at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Iron-deficiency, Iron Deficiency Anemia
What is being tested?
Consecutive Day Dosing and Alternate Day Dosing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteSwitzerland
Study dates
16 Dec 2021to 8 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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,
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

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

    Zurich, 8092

Other trials in Switzerland

About this study

Official 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

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.

Being tested
Consecutive Day Dosing, Alternate Day Dosing
Keywords
iron supplementation, dosing regimen, iron sulfate, women of reproductive age
Medical subject headings
Anemia, Iron-Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Consecutive Day DosingDietary supplement

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

  • Alternate Day DosingDietary supplement

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

Study groups in NCT05105438
Study groupRoleWhat they receive
Consecutive Day DosingActive comparator100 mg iron as FeSO4 daily for 3 months, followed by matched placebo daily for 3 months.
Receives: Dietary Supplement: Consecutive Day Dosing
Alternate Day DosingExperimental100 mg iron as FeSO4 and matched placebo on alternating days for 6 months.
Receives: Dietary Supplement: Alternate Day Dosing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum Ferritin (SF)

    in consecutive day group

    Measured: Day 93

  2. Serum Ferritin (SF)

    in alternate day group

    Measured: Day 186

  3. Event rate of GI side effects

    in consecutive day group

    Measured: Day 90

  4. Event rate of GI side effects

    in alternate day group

    Measured: Day 183

Secondary outcomes (55)

  1. Hemoglobin (Hb)

    Measured: Day 0

  2. Hemoglobin (Hb)

    Measured: Day 46

  3. Hemoglobin (Hb)

    Measured: Day 90

  4. Hemoglobin (Hb)

    Measured: Day 139

  5. Hemoglobin (Hb)

    Measured: Day 183

  6. Serum Ferritin (SF)

    Measured: Day 0

  7. Serum Ferritin (SF)

    Measured: Day 46

  8. Serum Ferritin (SF)

    Measured: Day 93

  9. Serum Ferritin (SF)

    Measured: Day 139

  10. Serum Ferritin (SF)

    Measured: Day 186

  11. Serum Transferrin Receptor (sTfR)

    Measured: Day 0

  12. Serum Transferrin Receptor (sTfR)

    Measured: Day 46

  13. Serum Transferrin Receptor (sTfR)

    Measured: Day 93

  14. Serum Transferrin Receptor (sTfR)

    Measured: Day 139

  15. Serum Transferrin Receptor (sTfR)

    Measured: Day 186

  16. Total iron binding capacity (TIBC)

    Measured: Day 0

  17. Total iron binding capacity (TIBC)

    Measured: Day 93

  18. Total iron binding capacity (TIBC)

    Measured: Day 186

  19. Serum Iron (SFe)

    Measured: Day 0

  20. Serum Iron (SFe)

    Measured: Day 93

  21. Serum Iron (SFe)

    Measured: Day 186

  22. C-Reactive Protein (CRP)

    Measured: Day 0

  23. C-Reactive Protein (CRP)

    Measured: Day 46

  24. C-Reactive Protein (CRP)

    Measured: Day 93

  25. C-Reactive Protein (CRP)

    Measured: Day 139

  26. C-Reactive Protein (CRP)

    Measured: Day 186

  27. Alpha-1-acid Glycoprotein (AGP)

    Measured: Day 0

  28. Alpha-1-acid Glycoprotein (AGP)

    Measured: Day 46

  29. Alpha-1-acid Glycoprotein (AGP)

    Measured: Day 93

  30. Alpha-1-acid Glycoprotein (AGP)

    Measured: Day 139

  31. Alpha-1-acid Glycoprotein (AGP)

    Measured: Day 186

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

    Measured: Day 0

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

    Measured: Day 90

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

    Measured: Day 183

  35. Calprotectin

    Measured: Day 0

  36. Calprotectin

    Measured: Day 90

  37. Calprotectin

    Measured: Day 183

  38. Hepcidin

    Measured: Day 0

  39. Hepcidin

    Measured: Day 46

  40. Hepcidin

    Measured: Day 90

  41. Hepcidin

    Measured: Day 139

  42. Hepcidin

    Measured: Day 183

  43. Event rate of GI side effects

    Measured: Day 90

  44. Event rate of GI side effects

    Measured: Day 183

  45. Incidence of GI side effects

    Measured: Day 90

  46. Incidence of GI side effects

    Measured: Day 183

  47. Event proportion of GI side effects

    Measured: Day 90

  48. Event proportion of GI side effects

    Measured: Day 183

  49. Severity of GI side effects

    Measured: Day 90

  50. Severity of GI side effects

    Measured: Day 183

  51. Fecal blood losses

    Measured: Day 0

  52. Fecal blood losses

    Measured: Day 90

  53. Fecal blood losses

    Measured: Day 183

  54. Iron absorption from supplements

    Measured: Day 90

  55. Iron absorption from supplements

    Measured: Day 183

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2021
  2. Study start16 Dec 2021
  3. Primary completion10 Aug 2022
  4. Study completion8 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05105438
Sponsor's protocol ID
CAPS_CH
Status last verified
Jan 2024
First submitted
22 Oct 2021
Last updated
24 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • von Siebenthal HK, Gessler S, Vallelian F, Steinwendner J, Kuenzi UM, Moretti D, Zimmermann MB, Stoffel NU. Alternate day versus consecutive day oral iron supplementation in iron-depleted women: a randomized double-blind placebo-controlled study. EClinicalMedicine. 2023 Nov 3;65:102286. doi: 10.1016/j.eclinm.2023.102286. eCollection 2023 Nov.

    PubMed 38021373

Questions about this trial

What is this clinical trial studying?

A study testing Consecutive Day Dosing and Alternate Day Dosing in people with Iron-deficiency and Iron Deficiency Anemia, run by Swiss Federal Institute of Technology at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Ferritin (SF) (time frame: Day 93). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05105438, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in