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

Not Applicable

Recruiting

• Conditions: Iron Deficiency Without Anemia

• Registration Number: NCT06851130
• Lead Sponsor: Swiss Federal Institute of Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-24
• Study Start: 2025-02-25
• Study First Posted: 2025-02-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-20
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serum ferritin	Study day 74	Serum ferritin concentration

Secondary Outcome Measures

Name	Time	Method
alpha(1)-acid-glycoprotein	Study day 74	alpha(1)-acid-glycoprotein concentration in serum
Serum ferritin	Study day 3	Serum ferritin concentration
Serum Ferritin	Study Day 1	Serum Ferritin concentration
Hemoglobin	Study day 74	Hemoglobin concentration
C-reactive protein	Study day 74	C-reactive protein concentration in serum

Trial Locations

Locations (1)

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