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

NCT06851130 | Recruiting

• 1 other identifier: INFER Study 2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Without Anemia

Keywords

serum ferritin; oral iron supplementation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (74)

• alpha(1)-acid-glycoprotein

  Study day 1

• Serum ferritin

  Study day 30

• Serum ferritin

  Study day 67

• Serum ferritin

  Study day 20

• Serum ferritin

  Study day 36

Study Arms (2)

80 mg

EXPERIMENTAL

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

160

EXPERIMENTAL

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

Interventions

ferrous sulfate 80 mg DIETARY_SUPPLEMENT

1 tablet per day

80 mg

ferrous sulfate 160 mg DIETARY_SUPPLEMENT

2 tablets per day

160

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

Study Sites (1)

Laboratory of Nutrition and Metabolic Epigenetics

Zurich, Canton of Zurich, 8092, Switzerland

RECRUITING

MeSH Terms

Conditions

Iron Deficiencies

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Nicole Stoffel, PhD

CONTACT

+41 44 632 83 93; nicole.stoffel@hest.ethz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 28, 2025
• Study Start: February 25, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

CH (1)