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CompletedNCT03623997Updated Aug 22, 2018

Measuring Erythrocyte Iron Incorporation From Different Dosing Regimens in Anemic Women

An observational study in Iron Deficiency Anemia, sponsored by Swiss Federal Institute of Technology. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-22.

Sponsored by Swiss Federal Institute of Technology · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 45 Years
Sex
Female
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Study summary

Iron-deficient anaemic subjects are likely to benefit most from oral iron supplements, but supplementation schedules vary widely in clinical practice, absorption is low and compliance is poor due to mild gastrointestinal side effects. The investigators will compare iron absorption from labeled oral iron doses of 100mg and 200mg administered either on two consecutive days or on alternate days in young anemic women.

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Conditions studied

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In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's enrollment of 20 is below the median of 200 across 326 observational studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Swiss Federal Institute of Technology is the lead sponsor of 152 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Young women with iron-deficiency anemia

Inclusion criteria

  • Ferritin \<15 µg/L
  • Hb 8-11.9 g/dl
  • BMI 18.5-24.9 kg/m2
  • Body weight \<70 kg

Exclusion criteria

Exclusion Criteria:

  • Severe anemia (Hb \<8 g/dl)
  • Elevated CRP >5.0 mg/L
  • Chronic disease
  • Long-term medication, except contraception
  • Consumption of Mineral and Vitamin supplements within the study period
  • Therapeutic iron infusion over the past 6 months
  • Pregnancy or breastfeeding
  • Smoking
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • Stable isotope labeled iron II sulfate

    All subjects will go through two iron absorption study cycles. In one cycle they get 100mg oral iron labeled with stable isotopes on two consecutive and on one alternate day and in another cycle they get 200mg oral iron labeled with stable isotopes on two consecutive and on one alternate day. Half of the subjects start with the 100mg cycle whereas the other half starts with the 200mg cycle.

    Other: Iron stable isotope labeled iron(II) sulfate

Interventions

  • OtherIron stable isotope labeled iron(II) sulfate

    Administration of oral stable isotope labels using different dosings and different regimens in women with iron deficiency anemia

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What researchers measure

Primary outcomes

  1. Fractional and total iron absorption

    Fractional and total iron absorption from different supplementation regimens

    Time frame: absorption will be measured 14days after the 100mg and 200mg cycle

  2. Serum hepcidin

    Serum hepcidin after the administration of different doses and using different regimens

    Time frame: right before the administration of an iron dose

  3. Serum EPO

    Serum EPO after the administration of different doses and using different

    Time frame: right before the administration of an iron dose

Secondary outcomes

  1. Serum ferritin

    Determination of iron status

    Time frame: right before the administration of an iron dose

  2. Serum TfR

    Determination of iron status

    Time frame: right before the administration of an iron dose

  3. Serum CRP

    Determination of inflammation status

    Time frame: right before the administration of an iron dose

  4. Serum AGP

    Determination of inflammation status

    Time frame: right before the administration of an iron dose

  5. Serum iron

    Determination of iron status

    Time frame: right before the administration of an iron dose

  6. Total iron binding capacity

    Determination of iron status

    Time frame: right before the administration of an iron dose

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Study locations

1 site
  • Human Nutrition Laboratory ETH Zurich
    Zurich, 8092, Switzerland
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References and documents

Publications

  • Stoffel NU, Zeder C, Brittenham GM, Moretti D, Zimmermann MB. Iron absorption from supplements is greater with alternate day than with consecutive day dosing in iron-deficient anemic women. Haematologica. 2020 May;105(5):1232-1239. doi: 10.3324/haematol.2019.220830. Epub 2019 Aug 14. PubMed 31413088 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03623997
Lead sponsor
Swiss Federal Institute of Technology
Responsible party
Prof. Michael B. Zimmermann (Prof. Dr. med, Swiss Federal Institute of Technology) — Principal investigator
First posted
Aug 9, 2018
Start date
Oct 10, 2017
Primary completion
Jan 8, 2018
Completion
Jun 30, 2018
Last update
Aug 22, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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