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

Swiss Federal Institute of Technology120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

120

Conditions

Iron Deficiency Without Anemia

Interventions

ferrous sulfate 80 mgDIETARY_SUPPLEMENT

1 tablet per day

ferrous sulfate 160 mgDIETARY_SUPPLEMENT

2 tablets per day

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Laboratory of Nutrition and Metabolic Epigenetics

Zurich, Canton of Zurich, Switzerland

RECRUITING

Outcomes

Primary Outcomes

Serum ferritin

Serum ferritin concentration

Time frame: Study day 31

Serum ferritin

Serum ferritin concentration

Time frame: Study day 37

Serum ferritin

Serum ferritin concentration

Time frame: Study day 68

Serum ferritin

Serum ferritin concentration

Time frame: Study day 74

Secondary Outcomes

alpha(1)-acid-glycoprotein

alpha(1)-acid-glycoprotein concentration in serum

Time frame: Study day 1

Serum ferritin

Serum ferritin concentration

Time frame: Study day 30

Serum ferritin

Serum ferritin concentration

Time frame: Study day 67

Serum ferritin

Serum ferritin concentration

Time frame: Study day 20

Serum ferritin

Serum ferritin concentration

Time frame: Study day 36

Serum ferritin

Serum ferritin concentration

Central Contacts

Nicole Stoffel, PhD

CONTACT

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

Data from ClinicalTrials.gov

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