Clinical trial NCT06851130: Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses: an Experimental Study in Iron-deficient Women
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: RECRUITING
Phase: NA
Conditions: Iron Deficiency Without Anemia
Keywords: serum ferritin
oral iron supplementation
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
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 following the administration of a daily iron dose for two months.


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 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

Primary outcomes:
measure: Serum ferritin
timeFrame: Study day 31
measure: Serum ferritin
timeFrame: Study day 37
measure: Serum ferritin
timeFrame: Study day 68
measure: Serum ferritin
timeFrame: Study day 74
Secondary outcomes:
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 1
measure: Serum ferritin
timeFrame: Study day 30
measure: Serum ferritin
timeFrame: Study day 67
measure: Serum ferritin
timeFrame: Study day 20
measure: Serum ferritin
timeFrame: Study day 36
measure: Serum ferritin
timeFrame: Study day 57
measure: Serum ferritin
timeFrame: Study day 72
measure: Serum ferritin
timeFrame: Study day 71
measure: Serum ferritin
timeFrame: Study day 70
measure: Serum ferritin
timeFrame: Study day 69
measure: Serum ferritin
timeFrame: Study day 73
measure: Serum ferritin
timeFrame: Study day 47
measure: Serum ferritin
timeFrame: Study day 35
measure: Serum ferritin
timeFrame: Study day 34
measure: Serum ferritin
timeFrame: Study day 33
measure: Serum ferritin
timeFrame: Study day 32
measure: Serum ferritin
timeFrame: Study day 10
measure: Serum ferritin
timeFrame: Study day 6
measure: Serum ferritin
timeFrame: Study day 3
measure: Serum Ferritin
timeFrame: Study Day 1
measure: Hemoglobin
timeFrame: Study day 1
measure: C-reactive protein
timeFrame: Study day 1
measure: C-reactive protein
timeFrame: Study day 3
measure: C-reactive protein
timeFrame: Study day 6
measure: C-reactive protein
timeFrame: Study day 10
measure: C-reactive protein
timeFrame: Study day 20
measure: C-reactive protein
timeFrame: Study day 30
measure: C-reactive protein
timeFrame: Study day 31
measure: C-reactive protein
timeFrame: Study day 32
measure: C-reactive protein
timeFrame: Study day 33
measure: C-reactive protein
timeFrame: Study day 34
measure: C-reactive protein
timeFrame: Study day 35
measure: C-reactive protein
timeFrame: Study day 36
measure: C-reactive protein
timeFrame: Study day 37
measure: C-reactive protein
timeFrame: Study day 47
measure: C-reactive protein
timeFrame: Study day 57
measure: C-reactive protein
timeFrame: Study day 67
measure: C-reactive protein
timeFrame: Study day 68
measure: C-reactive protein
timeFrame: Study day 69
measure: C-reactive protein
timeFrame: Study day 70
measure: C-reactive protein
timeFrame: Study day 71
measure: C-reactive protein
timeFrame: Study day 72
measure: C-reactive protein
timeFrame: Study day 73
measure: C-reactive protein
timeFrame: Study day 74
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 3
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 6
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 10
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 20
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 30
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 31
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 32
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 33
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 34
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 35
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 36
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 37
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 47
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 57
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 67
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 68
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 69
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 70
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 71
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 72
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 73
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 74
measure: Hemoglobin
timeFrame: Study day 10
measure: Hemoglobin
timeFrame: Study day 20
measure: Hemoglobin
timeFrame: Study day 30
measure: Hemoglobin
timeFrame: Study day 37
measure: Hemoglobin
timeFrame: Study day 47
measure: Hemoglobin
timeFrame: Study day 57
measure: Hemoglobin
timeFrame: Study day 67
measure: Hemoglobin
timeFrame: Study day 74
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Laboratory of Nutrition and Metabolic Epigenetics
Study officials:
References: