Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses: an Experimental Study in Iron-deficient Women (INFER 2)

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.

Study Overview

• Status: Recruiting
• Conditions: Iron Deficiency Without Anemia
• Intervention / Treatment: Dietary supplement: ferrous sulfate 80 mg; Dietary supplement: ferrous sulfate 160 mg

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicole Stoffel, PhD; Phone Number: +41 44 632 83 93; Email: nicole.stoffel@hest.ethz.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8092
    • Recruiting
    • Laboratory of Nutrition and Metabolic Epigenetics
    • Contact: Gian Tizio Rosalen, MSc; Phone Number: +41446328393; Email: giantizio.rosalen@hest.ethz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 80 mg; Daily dose of 80 mg of iron for 1 month, with a 7-day break, then again for another month (2 months total).	Dietary supplement: ferrous sulfate 80 mg; 1 tablet per day
Experimental: 160; Daily dose of 160 mg of iron for 1 month, with a 7-day break, then again for another month (2 months total).	Dietary supplement: ferrous sulfate 160 mg; 2 tablets per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum ferritin	Serum ferritin concentration	Study day 31
Serum ferritin	Serum ferritin concentration	Study day 37
Serum ferritin	Serum ferritin concentration	Study day 68
Serum ferritin	Serum ferritin concentration	Study day 74

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-reactive protein	C-reactive protein concentration in serum	Study day 1
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 1
Serum ferritin	Serum ferritin concentration	Study day 30
Serum ferritin	Serum ferritin concentration	Study day 67
Serum ferritin	Serum ferritin concentration	Study day 20
Serum ferritin	Serum ferritin concentration	Study day 36
Serum ferritin	Serum ferritin concentration	Study day 57
Serum ferritin	Serum ferritin concentration	Study day 72
Serum ferritin	Serum ferritin concentration	Study day 71
Serum ferritin	Serum ferritin concentration	Study day 70
Serum ferritin	Serum ferritin concentration	Study day 69
Serum ferritin	Serum ferritin concentration	Study day 73
Serum ferritin	Serum ferritin concentration	Study day 47
Serum ferritin	Serum ferritin concentration	Study day 35
Serum ferritin	Serum ferritin concentration	Study day 34
Serum ferritin	Serum ferritin concentration	Study day 33
Serum ferritin	Serum ferritin concentration	Study day 32
Serum ferritin	Serum ferritin concentration	Study day 10
Serum ferritin	Serum ferritin concentration	Study day 6
Serum ferritin	Serum ferritin concentration	Study day 3
Serum Ferritin	Serum Ferritin concentration	Study Day 1
Hemoglobin	Hemoglobin concentration	Study day 1
C-reactive protein	C-reactive protein concentration in serum	Study day 3
C-reactive protein	C-reactive protein concentration in serum	Study day 6
C-reactive protein	C-reactive protein concentration in serum	Study day 10
C-reactive protein	C-reactive protein concentration in serum	Study day 20
C-reactive protein	C-reactive protein concentration in serum	Study day 30
C-reactive protein	C-reactive protein concentration in serum	Study day 31
C-reactive protein	C-reactive protein concentration in serum	Study day 32
C-reactive protein	C-reactive protein concentration in serum	Study day 33
C-reactive protein	C-reactive protein concentration in serum	Study day 34
C-reactive protein	C-reactive protein concentration in serum	Study day 35
C-reactive protein	C-reactive protein concentration in serum	Study day 36
C-reactive protein	C-reactive protein concentration in serum	Study day 37
C-reactive protein	C-reactive protein concentration in serum	Study day 47
C-reactive protein	C-reactive protein concentration in serum	Study day 57
C-reactive protein	C-reactive protein concentration in serum	Study day 67
C-reactive protein	C-reactive protein concentration in serum	Study day 68
C-reactive protein	C-reactive protein concentration in serum	Study day 69
C-reactive protein	C-reactive protein concentration in serum	Study day 70
C-reactive protein	C-reactive protein concentration in serum	Study day 71
C-reactive protein	C-reactive protein concentration in serum	Study day 72
C-reactive protein	C-reactive protein concentration in serum	Study day 73
C-reactive protein	C-reactive protein concentration in serum	Study day 74
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 3
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 6
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 10
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 20
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 30
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 31
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 32
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 33
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 34
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 35
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 36
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 37
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 47
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 57
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 67
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 68
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 69
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 70
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 71
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 72
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 73
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 74
Hemoglobin	Hemoglobin concentration	Study day 10
Hemoglobin	Hemoglobin concentration	Study day 20
Hemoglobin	Hemoglobin concentration	Study day 30
Hemoglobin	Hemoglobin concentration	Study day 37
Hemoglobin	Hemoglobin concentration	Study day 47
Hemoglobin	Hemoglobin concentration	Study day 57
Hemoglobin	Hemoglobin concentration	Study day 67
Hemoglobin	Hemoglobin concentration	Study day 74

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): February 28, 2025

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: oral iron supplementation; serum ferritin
• Additional Relevant MeSH Terms: Metabolic Diseases; Iron Metabolism Disorders; Iron Deficiencies
• Other Study ID Numbers: INFER Study 2

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