Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses

NCT06657677 | Completed

• 1 other identifier: INFER Study 1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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

Conditions

Iron Deficiency (Without Anemia)

Keywords

oral iron supplementation; serum ferritin

Outcome Measures

Primary Outcomes (2)

• Serum ferritin

  Serum ferritin concentration

  study day 1

• Serum ferritin

  Serum ferritin concentration

  study day 7

Secondary Outcomes (27)

• C-reactive protein

  study day 0

• Serum ferritin

  study day 0

• Serum ferritin

  study day 6

• Serum ferritin

  study day 14

• Serum ferritin

  study day 5

Study Arms (3)

40 mg

EXPERIMENTAL

single dose of 40 mg oral iron

Dietary Supplement: 40mg oral iron dosing

100 mg

EXPERIMENTAL

single dose of 100 mg oral iron

Dietary Supplement: 100mg oral iron dosing

180 mg

EXPERIMENTAL

single dose of 180 mg oral iron

Dietary Supplement: 180mg oral iron dosing

Interventions

40mg oral iron dosing DIETARY_SUPPLEMENT

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

40 mg

100mg oral iron dosing DIETARY_SUPPLEMENT

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

100 mg

180mg oral iron dosing DIETARY_SUPPLEMENT

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

180 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• 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 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

Sponsors & Collaborators

• Jessica Rigutto: lead

Study Sites (2)

ETH Zurich

Zurich, Canton of Zurich, 8092, Switzerland

Location

Laboratory of Nutrition and Metabolic Epigenetics

Zurich, Canton of Zurich, 8092, Switzerland

Location

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nicole Stoffel, PhD

  ETH Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 24, 2024
• Study Start: October 25, 2024
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: February 27, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)