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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06851130
Acronym
INFER 2
Enrollment
120
Registered
2025-02-28
Start date
2025-02-25
Completion date
2025-12-31
Last updated
2025-05-20

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

serum ferritin, oral iron supplementation

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 following the administration of a daily iron dose for two months.

Interventions

DIETARY_SUPPLEMENTferrous sulfate 80 mg

1 tablet per day

DIETARY_SUPPLEMENTferrous sulfate 160 mg

2 tablets per day

Sponsors

Swiss Federal Institute of Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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 4 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 31Serum ferritin concentration

Secondary

MeasureTime frameDescription
alpha(1)-acid-glycoproteinStudy day 1alpha(1)-acid-glycoprotein concentration in serum
Serum ferritinStudy day 30Serum ferritin concentration
Serum FerritinStudy Day 1Serum Ferritin concentration
HemoglobinStudy day 1Hemoglobin concentration
C-reactive proteinStudy day 1C-reactive protein concentration in serum

Countries

Switzerland

Contacts

Primary ContactNicole Stoffel, PhD
nicole.stoffel@hest.ethz.ch+41 44 632 83 93

Outcome results

None listed

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