Clinical trial NCT06657677: Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses
Official title: Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses: an Experimental Study in Iron-deficient Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency (Without Anemia)
Keywords: oral iron supplementation
serum ferritin
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: Serum ferritin
timeFrame: study day 1
measure: Serum ferritin
timeFrame: study day 7
Secondary outcomes:
measure: C-reactive protein
timeFrame: study day 0
measure: Serum ferritin
timeFrame: study day 0
measure: Serum ferritin
timeFrame: study day 6
measure: Serum ferritin
timeFrame: study day 14
measure: Serum ferritin
timeFrame: study day 5
measure: Serum ferritin
timeFrame: study day 4
measure: Serum ferritin
timeFrame: study day 3
measure: Serum ferritin
timeFrame: study day 2
measure: alpha(1)-acid-glycoprotein
timeFrame: study day 0
measure: soluble transferrin receptor
timeFrame: study day 0
measure: Hemoglobin
timeFrame: study day 0
measure: Serum iron
timeFrame: study day 0
measure: Serum iron
timeFrame: study day 1
measure: Serum iron
timeFrame: study day 2
measure: Serum iron
timeFrame: study day 3
measure: Serum iron
timeFrame: study day 4
measure: Serum iron
timeFrame: study day 5
measure: Serum iron
timeFrame: study day 6
measure: Serum iron
timeFrame: study day 7
measure: Serum iron
timeFrame: study day 14
measure: Isotopic composition of Serum Ferritin
timeFrame: study day 0
measure: Isotopic composition of Serum Ferritin
timeFrame: study day 2
measure: Isotopic composition of Serum Ferritin
timeFrame: study day 7
measure: Structural characteristics of Serum Ferritin
timeFrame: study day 0
measure: Structural characteristics of Serum Ferritin
timeFrame: study day 2
measure: Structural characteristics of Serum Ferritin
timeFrame: study day 7
measure: Fractional iron absorption
timeFrame: study day 14
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: ETH Zurich
city: Zurich
country: Switzerland
facility: Laboratory of Nutrition and Metabolic Epigenetics
Study officials:
affiliation: ETH Zurich
name: Nicole Stoffel, PhD
role: PRINCIPAL_INVESTIGATOR
References: