Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses

Not Applicable

Completed

• Conditions: Iron Deficiency (Without Anemia)

• Registration Number: NCT06657677
• Lead Sponsor: Jessica Rigutto

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-23
• Study First Posted: 2024-10-24
• Study Start: 2024-10-25
• Primary Completion: 2024-12-16
• Study Completion: 2024-12-16
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serum ferritin	study day 7	Serum ferritin concentration

Secondary Outcome Measures

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

Trial Locations

Locations (2)

ETH Zurich; 🇨🇭 Zurich, Switzerland

Laboratory of Nutrition and Metabolic Epigenetics; 🇨🇭 Zurich, Switzerland