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Recruiting NCT07394972

Absorption of Iron From Stabilized Lactoferrin: A Study in Women With Iron Deficiency

No phase Interventional Iron Deficiency (Without Anemia)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FeSO4 + meal-matrix, FeSO4 + native LF + meal-matrix, FeSO4 + NaCas-LF + meal-matrix, NaCas-LF-Fe + meal-matrix.
Who it may be relevant to
Registry conditions: Iron Deficiency (Without Anemia). Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Iron Absorption From Stabilized Lactoferrin: An Experimental Study in Iron Deficient Women (LOBSTER)

Overview

Lactoferrin (LF) is a natural iron-binding protein found in milk. It exists either in an iron-free state (apo-LF) or bound to iron (holo-LF). Whether LF binds iron to facilitate its absorption and/or to sequester iron from potential enteropathogens remains uncertain. However, while LF is a promising tool for treating iron deficiency, it is sensitive to heat during food processing and to the acidic environment of the human stomach. This degradation often causes LF to lose its functional properties before it can promote iron absorption effectively. This study aims to evaluate whether encapsulating apo-LF (either alone or in combination with iron) can protect LF from digestion and enhance iron absorption. Using a randomized, crossover design, different encapsulation methods will be compared to determine which results in the highest iron absorption in women with iron deficiency. All test compounds will be labeled with stable iron isotopes. Participants will consume the labeled compounds with a test meal or water in a randomized order, allowing for within subject comparisons. Fractional iron absorption will be measured 17 days after administration via the incorporation of labeled iron into red blood cells.

Interventions

  • Other FeSO4 + meal-matrix
    Maize porridge with labelled ferrous sulfate (58Fe)
  • Other FeSO4 + native LF + meal-matrix
    Maize porridge with labelled ferrous sulfate (58Fe) and lactoferrin
  • Other FeSO4 + NaCas-LF + meal-matrix
    Maize porridge with labelled ferrous sulfate (57Fe) and in sodium caseinate encapsulated lactoferrin
  • Other NaCas-LF-Fe + meal-matrix
    Maize porridge with sodium caseinate-lactoferrin-Fe (intrinsically labeled with iron isotope 54)
  • Other FeSO4 + LMP-LF + meal-matrix
    Maize porridge with labelled ferrous sulfate (54Fe) and low methoxy pectin lactoferrin
  • Other LMP-LF-Fe + meal-matrix
    Maize porridge with low methoxy pectin-lactoferrin-Fe (intrinsically labelled with iron isotope 57)
  • Other NaCas-LF-Fe + water
    Water with sodium caseinate-lactoferrin-Fe (intrinsically labelled with iron isotope 54Fe)
  • Other LMP-LF-Fe + water
    Water with low methoxy pectin-lactoferrin-Fe (intrinsically labelled with iron isotope 57Fe)
  • Other FeSO4 + water
    Water with ferrous sulfate (labelled with iron isotope 58Fe)

Primary outcome measures

  • Fractional iron absorption (%) [Time frame: Day 22]
  • Fractional iron absorption (%) [Time frame: Day 43]
  • Fractional iron absorption (%) [Time frame: Day 64]
Secondary outcome measures (12)
  • Hemoglobin (g/dL) [Time frame: Day 1]
  • Hemoglobin (g/dL) [Time frame: Day 22]
  • Hemoglobin (g/dL) [Time frame: Day 43]
  • Hemoglobin (g/dL) [Time frame: Day 64]
  • Serum Ferritin (µg/L) [Time frame: Day 1]
  • Serum Ferritin (µg/L) [Time frame: Day 22]
  • Serum Ferritin (µg/L) [Time frame: Day 43]
  • soluble Transferrin Receptor (mg/L) [Time frame: Day 1]
  • soluble Transferrin Receptor (mg/L) [Time frame: Day 22]
  • soluble Transferrin Receptor (mg/L) [Time frame: Day 43]
  • C-reactive protein (mg/L) [Time frame: Day 1]
  • C-reactive protein (mg/L) [Time frame: Day 22]

Eligibility criteria

Inclusion criteria

  • Serum ferritin < 45 µg/L (iron depleted)
  • Body weight < 70 kg
  • Body mass index 18,5 - 24,9 kg/m2 (normal weight)
  • Hemoglobin (Hb) > 120 g/L (nonanemic)
  • C-reactive protein (CRP) < 5 mg/L (no inflammation)

Exclusion criteria

  • Pregnant or lactating
  • Strictly vegan
  • Cigarette smoking (> 1 cigarette / week)
  • Gastrointestinal or metabolic disorders affecting iron absorption or metabolism
  • Use of medication known to affect iron metabolism (oral contraceptives are allowed)
  • Intake of vitamin and mineral supplements in the 2 weeks before study start and during the study
  • Blood transfusion, blood donation, or significant blood loss during the previous 4 months
  • once enrolled, inability to follow study procedures or major illness
  • Participation in another study with investigational drug within the 30 days preceding and during the present study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Other

Study locations

Switzerland · 1 center
  • ETH Zurich, Laboratory of Clinical Biopharmacy — Zurich

Identifiers

NCT: NCT07394972 · LOBSTER

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗