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Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses

Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses: an Experimental Study in Iron-deficient Women.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06657677
Enrollment
46
Registered
2024-10-24
Start date
2024-10-25
Completion date
2024-12-16
Last updated
2025-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency (Without Anemia)

Keywords

oral iron supplementation, serum ferritin

Brief summary

Serum ferritin is a key indicator of body iron stores and is widely used in monitoring iron status. However, oral iron doses can acutely elevate SF levels, potentially biasing assessments of iron stores during supplementation. This study aims to investigate the extent and duration of the acute iron-induced effect on serum ferritin, as well as its protein characteristics, following the administration of a single iron dose

Interventions

DIETARY_SUPPLEMENT40mg oral iron dosing

Participants will receive a single morning oral dose of iron as Fe57-labelled ferrous sulfate

DIETARY_SUPPLEMENT100mg oral iron dosing

Participants will receive a single morning oral dose of iron as Fe57-labelled ferrous sulfate

DIETARY_SUPPLEMENT180mg oral iron dosing

Participants will receive a single morning oral dose of iron as Fe57-labelled ferrous sulfate

Sponsors

Jessica Rigutto
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Low iron stores (SF levels \< 30 µg/L), * no anemia (Hb \> 120 g/L) * no inflammation (CRP \< 5 mg/L) * 18 to 45 years old. * Body weight \<70 kg * Normal body Mass Index (18.5-26.5 kg/m2)

Exclusion criteria

* Any chronic or acute disease * Consumption of mineral and vitamin supplements since screening and over the study period * Blood transfusion, blood donation or significant blood loss over the past 6 months, * Pregnant or breastfeeding, * Continuous/long-term use of medication during the whole studies (except for contraceptives) * Therapeutic iron infusion over the past 6 months, * Known hypersensitivity or allergy to iron supplements, * Intention to become pregnant over the course of the study

Design outcomes

Primary

MeasureTime frameDescription
Serum ferritinstudy day 1Serum ferritin concentration

Secondary

MeasureTime frameDescription
Serum ironstudy day 0serum iron concentration in circulation
Isotopic composition of Serum Ferritinstudy day 0shift in stable iron isotopes in serum ferritin
Structural characteristics of Serum Ferritinstudy day 0Proteomics
Fractional iron absorptionstudy day 14Erythrocyte iron incorporation of stable iron isotope
Hemoglobinstudy day 0Hemoglobin concentration
Serum ferritinstudy day 0Serum ferritin concentration
alpha(1)-acid-glycoproteinstudy day 0alpha(1)-acid-glycoprotein concentration in serum
soluble transferrin receptorstudy day 0soluble transferrin receptor in serum
C-reactive proteinstudy day 0C-reactive protein concentration in serum

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026