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

RecruitingNAAges 18 Years - 45 YearsFemaleNicole Stoffel
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In plain words

What the trial is, and whether it could suit you

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 c

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Serum ferritin \< 45 ยตg/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
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What it tests

  • FeSO4 + meal-matrix
  • FeSO4 + native LF + meal-matrix
  • FeSO4 + NaCas-LF + meal-matrix
  • NaCas-LF-Fe + meal-matrix
  • FeSO4 + LMP-LF + meal-matrix
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Where

1 site
ETH Zurich, Laboratory of Clinical Biopharmacy
Zurich, Switzerland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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