Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT07394972

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

Led by Nicole Stoffel · Updated on 2026-02-12

45

Participants Needed

1

Research Sites

10 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Serum ferritin less than 45 g/L indicating iron depletion
  • Body weight less than 70 kg
  • Body mass index between 18.5 and 24.9 kg/m2 (normal weight)
  • Hemoglobin greater than 120 g/L (nonanemic)
  • C-reactive protein less than 5 mg/L (no inflammation)
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women
  • Strict vegans
  • Smoking more than 1 cigarette per week
  • Gastrointestinal or metabolic disorders affecting iron absorption or metabolism
  • Use of medication affecting iron metabolism (oral contraceptives allowed)
  • Use of vitamin or mineral supplements within 2 weeks before and during the study
  • Blood transfusion, donation, or significant blood loss within 4 months
  • Inability to follow study procedures or having a major illness
  • Participation in another study with investigational drug within 30 days before or during this study

AI-Screening

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Trial Site Locations

Total: 1 location

1

ETH Zurich, Laboratory of Clinical Biopharmacy

Zurich, Switzerland, 8092

Actively Recruiting

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Research Team

S

Salome Häcki, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

9

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