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.

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

Study Overview

• Status: Completed
• Conditions: Iron Deficiency (Without Anemia)
• Intervention / Treatment: Dietary supplement: 40mg oral iron dosing; Dietary supplement: 100mg oral iron dosing; Dietary supplement: 180mg oral iron dosing

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8092
    • ETH Zurich
  • Zurich, Switzerland, 8092
    • Laboratory of Nutrition and Metabolic Epigenetics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 40 mg; single dose of 40 mg oral iron	Dietary supplement: 40mg oral iron dosing; Participants will receive a single morning oral dose of iron as Fe57-labelled ferrous sulfate
Experimental: 100 mg; single dose of 100 mg oral iron	Dietary supplement: 100mg oral iron dosing; Participants will receive a single morning oral dose of iron as Fe57-labelled ferrous sulfate
Experimental: 180 mg; single dose of 180 mg oral iron	Dietary supplement: 180mg oral iron dosing; Participants will receive a single morning oral dose of iron as Fe57-labelled ferrous sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum ferritin	Serum ferritin concentration	study day 1
Serum ferritin	Serum ferritin concentration	study day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum ferritin	Serum ferritin concentration	study day 0
Serum ferritin	Serum ferritin concentration	study day 2
Serum ferritin	Serum ferritin concentration	study day 3
Serum ferritin	Serum ferritin concentration	study day 4
Serum ferritin	Serum ferritin concentration	study day 5
Serum ferritin	Serum ferritin concentration	study day 6
Serum ferritin	Serum ferritin concentration	study day 14
C-reactive protein	C-reactive protein concentration in serum	study day 0
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	study day 0
soluble transferrin receptor	soluble transferrin receptor in serum	study day 0
Hemoglobin	Hemoglobin concentration	study day 0
Serum iron	serum iron concentration in circulation	study day 0
Serum iron	serum iron concentration in circulation	study day 1
Serum iron	serum iron concentration in circulation	study day 2
Serum iron	serum iron concentration in circulation	study day 3
Serum iron	serum iron concentration in circulation	study day 4
Serum iron	serum iron concentration in circulation	study day 5
Serum iron	serum iron concentration in circulation	study day 6
Serum iron	serum iron concentration in circulation	study day 7
Serum iron	serum iron concentration in circulation	study day 14
Isotopic composition of Serum Ferritin	shift in stable iron isotopes in serum ferritin	study day 0
Isotopic composition of Serum Ferritin	shift in stable iron isotopes in serum ferritin	study day 2
Isotopic composition of Serum Ferritin	shift in stable iron isotopes in serum ferritin	study day 7
Structural characteristics of Serum Ferritin	Proteomics	study day 0
Structural characteristics of Serum Ferritin	Proteomics	study day 2
Structural characteristics of Serum Ferritin	Proteomics	study day 7
Fractional iron absorption	Erythrocyte iron incorporation of stable iron isotope	study day 14

Collaborators and Investigators

• Sponsor: Jessica Rigutto
• Investigators: Principal Investigator: Nicole Stoffel, PhD, ETH Zurich

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2024
• Primary Completion (Actual): December 16, 2024
• Study Completion (Actual): December 16, 2024

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: oral iron supplementation; serum ferritin
• Additional Relevant MeSH Terms: Metabolic Diseases; Iron Metabolism Disorders; Iron Deficiencies; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: INFER Study 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No